Revvity Health Sciences, Inc.
Boston, MA, US
Revvity Health Sciences, Inc. appears in FDA device records in Boston, MA. FDA records list 81 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 52 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to Revvity Health Sciences, 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.
- Perkin Elmer Health Sciences, Inc.enforcement report, recall
- Perkin Elmer Life and Analytical Sciences Increcall
- PerkinElmer Health Sciences, Inc.enforcement report, recall
- PerkinElmer LAS, Increcall
- Perkinelmer Life Sciences, Inc.510(k), enforcement report, recall
- Perkinelmer, Inc.510(k), enforcement report, recall
- The Perkin-Elmer Corp.510(k), recall
510(k) clearance history
Showing 50 of 81FDA records hold 81 510(k) clearances for Revvity Health Sciences, Inc. between 1976 and 2022. The busiest year on record is 1977, with 13. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 13 |
| 1978 | 7 |
| 1979 | 7 |
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 4 |
| 1983 | 5 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 5 |
| 1989 | 2 |
| 1990 | 1 |
| 1994 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2009 | 2 |
| 2010 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | PJI | Substantially Equivalent | |
| DEN200044 | Eonis SCID-SMA Kit | QUE | Unknown | |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | NQL | Substantially Equivalent | |
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | QJE | Unknown | |
| K190335 | GSP Neonatal Total Galactose kit | JIA | Substantially Equivalent | |
| K190266 | NeoLSD MSMS Kit | PQW | Substantially Equivalent | |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | MQB | Substantially Equivalent | |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | MQB | Substantially Equivalent | |
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | PJC | Substantially Equivalent | |
| K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR | MQB | Substantially Equivalent | |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | NQL | Substantially Equivalent | |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | KQP | Substantially Equivalent | |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | NAK | Substantially Equivalent | |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | JLW | Substantially Equivalent | |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | NQL | Substantially Equivalent | |
| DEN040002 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 | NQL | Unknown | |
| K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | JNB | Substantially Equivalent | |
| K935666 | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | KIE | Substantially Equivalent | |
| K900828 | PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. | JXR | Substantially Equivalent | |
| K884864 | PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO | JJQ | Substantially Equivalent | |
| K884886 | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | LDM | Substantially Equivalent | |
| K872737 | PERKIN-ELMER LC235 DIODE ARRAY DETECTOR | Substantially Equivalent | ||
| K872464 | ION TRAP DETECTOR (ITD) | DOP | Substantially Equivalent | |
| K871550 | PFI-20 POLARIZING FLUORIMETER | KHO | Substantially Equivalent | |
| K872122 | 8000 SERIES GAS CHROMATOGRAPHS | KZQ | Substantially Equivalent | |
| K870661 | LIFEWATCH PLUS | BZQ | Substantially Equivalent | |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | CCK | Substantially Equivalent | |
| K862178 | ISOPURE LC SYSTEM | LDM | Substantially Equivalent | |
| K860197 | SERIES 410 LC PUMP | KZR | Substantially Equivalent | |
| K853840 | LIFE WATCH RESPIRATORY MONITOR | CHL | Substantially Equivalent | |
| K843568 | LIQUID CHROMATOGRAPH 400 | KZR | Substantially Equivalent | |
| K842752 | ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT | JXR | Substantially Equivalent | |
| K842496 | ICP/6500 INDUCTIVELY-COUPLED PLASMA- | JXR | Substantially Equivalent | |
| K840977 | LIQUID CHROMATOGRAPHIC DETECTOR LC-95 | KZR | Substantially Equivalent | |
| K832767 | ADVANTAGE #1700 | CCK | Substantially Equivalent | |
| K831387 | HS-100 HEADSPACE SAMPLING ACCESSORY | KZQ | Substantially Equivalent | |
| K831758 | FLOW-CALIBRATION MODULE | BXW | Substantially Equivalent | |
| K830799 | INDUCTIVELY-COUPLED PLASMA SPECTROMETER | JXR | Substantially Equivalent | |
| K830147 | SIGMA 300 GAS CHROMATROGRAPH | KZQ | Substantially Equivalent | |
| K821727 | SERIES 10 LIQUID CHROMOTOGRAPH | LDM | Substantially Equivalent | |
| K821219 | SERIES 4 LIQUID CHROMATOGRAPH | LDM | Substantially Equivalent | |
| K820320 | MODEL 3030 ATOMIC ABSORPTION SPECTRO- | JXR | Substantially Equivalent | |
| K820283 | SIGMA 2000 GAS CHROMATOGRAPH | KZQ | Substantially Equivalent | |
| K810536 | ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB | JXR | Substantially Equivalent | |
| K810304 | MODEL LC-85 UV DETECTOR | LDM | Substantially Equivalent | |
| K800086 | RMS 111F RESPIRATORY MONITORING SYSTEM | BZK | Substantially Equivalent | |
| K800087 | ULTRASONIC FLOWMETER | BXP | Substantially Equivalent | |
| K792557 | SPECTROPHATOMETER MODELS 2280 & 2380AA | JXR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1224609 | 1000513616 | Revvity Health Sciences, Inc. | 549 ALBANY ST., BOSTON, MA 02118 US | 2026 | No device listings on this registration |
| 3007145015 | 3007145015 | Revvity Health Sciences, Inc. | 17 P&N Drive, Greenville, SC 29611 US | 2026 | |
| 3009981484 | 3009981484 | Revvity Health Sciences, Inc. | 68 Elm St, Hopkinton, MA 01748 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- KIEApparatus, High Pressure Liquid Chromatography
- JXRAtomic Absorption Spectrophotometer, General Use
- OIBBlood And Urine Collection Kit (Excludes Hiv Testing)
- BXWCalibrator, Volume, Gas
- KZRChromatography (Liquid, Gel), Clinical Use
- KZQChromatography(Gas), Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- JRICuvette, Thermostated
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JIAEnzymatic Methods, Galactose
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- KHOFluorometer, For Clinical Use
- LDMInstrumentation, High Pressure Liquid Chromatography
- DOPMass Spectrometer, Clinical Use
- DPHMercury, Atomic Absorption
- BZQMonitor, Breathing Frequency
- QJEMuscular Dystrophy Newborn Screening Test
- PJCNewborn Screening Specimen Collection Paper
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- QUESpinal Muscular Atrophy Newborn Screening Test System
- BZKSpirometer, Monitoring (W/Wo Alarm)
- JQWStation, Pipetting And Diluting, For Clinical Use
- NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- NAKSystem, Test, Biotinidase
- BXPTransducer, Gas Flow
Recall records
Showing 25 of 52| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2264-2020 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. | Class III | Terminated | |
| Z-0728-2018 | JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. | We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing production final acceptance testing due to a Horizontal Motion Error message displayed on the system. Further investigation concluded that two printed circuit boards (PCB) used in MDT models of Janus and Janus G3 were manufactured with the incorrect resistor values. This anomaly affects component part number 7101640 (PCB-Quad Motor Controller MDT) and part number 7101647 (PCB-Quad Motor Controller Gripper). This anomaly could result in the Horizontal Motion Error being displayed and result in instrument down time. Until PerkinElmer s corrective measures are completed, we request you; Be aware that there is potential for the Horizontal Motion Error message to display which could result in instrument down time. Follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays. If you have additional questions, contact PerkinElmer Technical Support for further assistance (800) 762-4000. | Class III | Terminated | |
| Z-2756-2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening. | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. | Class III | Terminated | |
| Z-2685-2017 | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. | Potential for electric shock in the case of a failure to install the grommets, supplied with the system. | Class II | Terminated | |
| Z-1102-2017 | DELFIA PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | Terminated | |
| Z-1101-2017 | Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | Terminated | |
| Z-1100-2017 | AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | Terminated | |
| Z-0897-2017 | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U | Unique Device Identifier (UDI) is missing from outer kit box label. | Class III | Terminated | |
| Z-0902-2017 | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports | Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating. | Class II | Terminated | |
| Z-0779-2017 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L. | Class III | Terminated | |
| Z-0780-2017 | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS | Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. | Class II | Terminated | |
| Z-0747-2017 | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows | Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing | Class II | Terminated | |
| Z-0638-2016 | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0637-2016 | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0636-2016 | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0635-2016 | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0634-2016 | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0633-2016 | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-0632-2016 | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. | Class II | Terminated | |
| Z-2130-2015 | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated | |
| Z-2129-2015 | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated | |
| Z-2128-2015 | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated | |
| Z-2127-2015 | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated | |
| Z-2126-2015 | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated | |
| Z-2125-2015 | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain