Agilent Technologies, Inc.
Winooski, VT, US
Agilent Technologies, Inc. appears in FDA device records in Winooski, VT. FDA records list 51 510(k) clearances between and , 75 PMA records and 5 registered establishments. As of , FDA records show 27 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Agilent Technologies, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- BioTek Instruments, Inc.recall
- Dako North America, Inc.510(k), PMA, enforcement report, recall
- Dakocytomation California, Inc.510(k), recall
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Agilent Technologies, Inc. between 1982 and 2017. The busiest year on record is 2000, with 21. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1985 | 2 |
| 1989 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 21 |
| 2001 | 12 |
| 2005 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal Assay | PFX | Substantially Equivalent | |
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) | MXZ | Substantially Equivalent | |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | MXZ | Substantially Equivalent | |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | MYA | Substantially Equivalent | |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | MYA | Substantially Equivalent | |
| K060423 | CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES | GKZ | Substantially Equivalent | |
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | MXZ | Substantially Equivalent | |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | |
| K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | DSI | Substantially Equivalent | |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B | MKJ | Substantially Equivalent | |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | MKJ | Substantially Equivalent | |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 | MHX | Substantially Equivalent | |
| K010453 | M2376A DEVICELINK SYSTEM | MWI | Substantially Equivalent | |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | |
| K010048 | M2376A DEVICELINK SYSTEM | MWI | Substantially Equivalent | |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | |
| K003621 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 | MHX | Substantially Equivalent | |
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A | MKJ | Substantially Equivalent | |
| K003622 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K002459 | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K003107 | M2376A DEVICELINK SYSTEM | MWI | Substantially Equivalent | |
| K002967 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER | IYN | Substantially Equivalent | |
| K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A | MKJ | Substantially Equivalent | |
| K002397 | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER | IYN | Substantially Equivalent | |
| K002009 | HP M2376A DEVICE LINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K001776 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A | MWI | Substantially Equivalent | |
| K001664 | COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 | MHX | Substantially Equivalent | |
| K001711 | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 | IYN | Substantially Equivalent | |
| K001436 | AGILENT M2636A TELEMON MONITOR | DSI | Substantially Equivalent | |
| K994188 | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 | CBQ | Substantially Equivalent | |
| K001348 | ST/AR ST AND ARRHYTHMIA SOFTWARE | MHX | Substantially Equivalent | |
| K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW | DQA | Substantially Equivalent | |
| K001057 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR | DSI | Substantially Equivalent | |
| K000854 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER | MHX | Substantially Equivalent | |
| K000822 | AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR | DSI | Substantially Equivalent | |
| K000635 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM | MWI | Substantially Equivalent | |
| K993907 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 | MHD | Substantially Equivalent | |
| K990093 | ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW | DSI | Substantially Equivalent | |
| K980186 | ZYMED TELEMETRY SYSTEM | DSI | Substantially Equivalent | |
| K942781 | DIGITAL HOLTER RECORDER | DSH | Substantially Equivalent | |
| K930806 | ZYMED HOLTER SCANNER MODEL 2010 | DQK | Substantially Equivalent | |
| K924672 | ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) | DSI | Substantially Equivalent | |
| K895208 | ZYMED MODEL 1610 | DSI | Substantially Equivalent | |
| K854213 | ARI STANDARD ANESTHESIA RECORD | BSZ | Substantially Equivalent | |
| K841083 | QUIKPAGE ARRHYTHMIA REPORT GENERATOR | DSI | Substantially Equivalent | |
| K822970 | HOLTER RECORDER | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009202467 | 3009202467 | Agilent Technologies | Hewlett-Packard-Strasse 8, Waldbronn Baden-Wurttemberg BW 76337 DE | 2026 | |
| 3009189893 | 3009189893 | Agilent Technologies Inc. | 1834 State Highway 71 West, Cedar Creek, TX 78612 US | 2026 | and 60 more, listed in full below |
| 2916205 | 2916205 | Agilent Technologies, Inc | 5301 Stevens Creek Blvd, Santa Clara, CA 95051 US | 2026 | and 30 more, listed in full below |
| 1217454 | 1217454 | Agilent Technologies, Inc. | 100 Tigan St, Winooski, VT 05404 US | 2026 | |
| 2022180 | 2022180 | Agilent Technologies, Inc. | 6392 VIA REAL, CARPINTERIA, CA 93013 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IDFAcid, Fuchsin
- KEMAgent, Clearing
- DDZAlbumin, Fitc, Antigen, Antiserum, Control
- IDAAlcian Blue
- ICZAmmoniacal Silver Hydroxide Silver Nitrate
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- KFDAniline Blue
- JJNApparatus, Electrophoresis, For Clinical Use
- KIEApparatus, High Pressure Liquid Chromatography
- JTQBath, Incubators/Water, All
- JITCalibrator, Secondary
- ICLCarbol Fuchsin
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DQKComputer, Diagnostic, Programmable
- ICHCongo Red
- GKZCounter, Differential Cell
- KESCoverslips, Microscope Slide
- ICFCrystal Violet For Histology
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- HYBEosin Y
- BSZGas-Machine, Anesthesia
- HYFGiemsa Stain
- HYJHematoxylin
- HYLHematoxylin Mayer'S
- CZPIga, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DGKIgg, Fitc, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- DFSIgm, Fitc, Antigen, Antiserum, Control
- JMRImmunochemical, Lysozyme (Muramidase)
- GGHIron Stains
- DFHKappa, Antigen, Antiserum, Control
- DEOKappa, Fitc, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- DESLambda, Fitc, Antigen, Antiserum, Control
- HYSLight Green
- DOPMass Spectrometer, Clinical Use
- HYZMethenamine Silver
- HZAMethyl Green
- IBKMicroscope, Fluorescence/U.V.
- HZCMucicarmine
- HZDMuller'S Colloidal Iron
- HZFNuclear Fast Red
- DQAOximeter
- JZJPrealbumin, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- HZTReagent, Schiff
- DSHRecorder, Magnetic Tape, Medical
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- HZXSilver Nitrate
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KEWSlides, Microscope
- JQWStation, Pipetting And Diluting, For Clinical Use
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DGRWhole Human Serum, Antigen, Antiserum, Control
Recall records
Showing 25 of 27| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1544-2025 | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder. | Class II | Open, Classified | |
| Z-1919-2024 | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A | There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury. | Class II | Open, Classified | |
| Z-1384-2022 | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512 | Label provided for substrate vail contained incorrect expiration date. | Class III | Open, Classified | |
| Z-2359-2019 | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. | When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made. | Class II | Terminated | |
| Z-2425-2018 | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options. | To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months. | Class II | Terminated | |
| Z-2099-2016 | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. | An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low. | Class II | Terminated | |
| Z-0220-2016 | EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use. | There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results. | Class II | Terminated | |
| Z-1737-2017 | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies. | The product was marketed without 510(k) clearance. | Class II | Terminated | |
| Z-1548-2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems. | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected. | Class II | Terminated | |
| Z-1261-2015 | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. | A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014. | Class II | Terminated | |
| Z-2708-2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the Autostainer Link 48 automated workstations operating either singly or in networked configurations. | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely aligned. | Class II | Terminated | |
| Z-1093-2014 | Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. | Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. | Class II | Terminated | |
| Z-2223-2009 | BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. | Software design allowed false negatives to be read when wells are dark. | Terminated | ||
| Z-0287-2013 | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. | Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open. | Class II | Terminated | |
| Z-0320-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0319-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4010 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0318-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4009 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0317-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0316-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4007 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0315-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0314-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4005 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0313-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0312--06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0311-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated | ||
| Z-0310-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain