EMD Millipore Corporation
Burlington, MA, US
EMD MILLIPORE CORPORATION appears in FDA device records in Burlington, MA. FDA records list 94 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to EMD Millipore Corporation 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.
- Emd Chemicals, Inc.510(k), recall
- Millipore Corporation510(k), PMA, recall
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for EMD Millipore Corporation between 1977 and 2010. The busiest year on record is 1982, with 34. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 4 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 34 |
| 1983 | 16 |
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 4 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1994 | 4 |
| 1995 | 4 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | OMG | Substantially Equivalent | |
| K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | GQL | Substantially Equivalent | |
| K031367 | DUOPATH VEROTOXINS GLISA TEST | GNA | Substantially Equivalent | |
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | BSN | Substantially Equivalent | |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | BSN | Substantially Equivalent | |
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DNN | Substantially Equivalent | |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DLJ | Substantially Equivalent | |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DNN | Substantially Equivalent | |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | BSN | Substantially Equivalent | |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | CIJ | Substantially Equivalent | |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | LFR | Substantially Equivalent | |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | CEK | Substantially Equivalent | |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | CEK | Substantially Equivalent | |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | CEO | Substantially Equivalent | |
| K945368 | PHOSPHORUS TEST (PHOS) | CEO | Substantially Equivalent | |
| K941326 | ULTRAFREE-CL | JJH | Substantially Equivalent | |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | FIB | Substantially Equivalent | |
| K924347 | WATERS(TM) 996 PDA | KIE | Substantially Equivalent | |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | LDM | Substantially Equivalent | |
| K920136 | WATERS 717 AUTOSAMPLER | LDM | Substantially Equivalent | |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | KIE | Substantially Equivalent | |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | LDM | Substantially Equivalent | |
| K872792 | WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM | Substantially Equivalent | ||
| K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | LDM | Substantially Equivalent | |
| K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | LDM | Substantially Equivalent | |
| K864267 | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) | DPM | Substantially Equivalent | |
| K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | KIE | Substantially Equivalent | |
| K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | LDM | Substantially Equivalent | |
| K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | LDM | Substantially Equivalent | |
| K841403 | HEMO-RO WATER PURIFICATION SYS | FIP | Substantially Equivalent | |
| K840883 | UNIPAK 100 ANALYZER, 65156 & CHEMISTR | JJE | Substantially Equivalent | |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | GIF | Substantially Equivalent | |
| K834294 | ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB | LCP | Substantially Equivalent | |
| K833448 | EPOS CHEMISTRY ANALYZER 5060 & 6410 | JJE | Substantially Equivalent | |
| K833017 | SERUM IRON & TIBC#65084 & 65085 | JIY | Substantially Equivalent | |
| K832952 | MILLIPORE IVEX INT FILTER UNIT | FPB | Substantially Equivalent | |
| K832480 | TRUST RPR TITRATION CARD TEST #65145 | GMQ | Substantially Equivalent | |
| K832479 | TRUST RPR CARD TEST #65144 | GMQ | Substantially Equivalent | |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | KEA | Substantially Equivalent | |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | JCE | Substantially Equivalent | |
| K830832 | RHEUMATOID FACTOR-RAPID CARD TEST #65114 | DHR | Substantially Equivalent | |
| K830241 | ULTRA CHEM BUN-UV #65080-65081 | CDQ | Substantially Equivalent | |
| K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA | CHH | Substantially Equivalent | |
| K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE | CHH | Substantially Equivalent | |
| K830308 | ULTRA ZYME PLUS GAMMA GT #65055 & 56 | JQB | Substantially Equivalent | |
| K830240 | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 | JQB | Substantially Equivalent | |
| K830238 | ULTRA CHEM CRESOLCAVERSACHEM #65082 | CIC | Substantially Equivalent | |
| K823883 | ULTRAZYME PLUS GAMMA-GT, #64959/65032 | JQB | Substantially Equivalent | |
| K823300 | BUN-UN CENTRIFICHUM 500, #65080/81 | CDQ | Substantially Equivalent | |
| K823472 | ULTRA CHEM BAN-UV #65080 & 65081 | CDQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009432145 | 2244894 | EMD MILLIPORE CORPORATION | 400 Summit Drive, Burlington, MA 01803 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IDFAcid, Fuchsin
- CDOAcid, Uric, Uricase (U.V.)
- IDAAlcian Blue
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GLZAntigens, If, Toxoplasma Gondii
- GMQAntigens, Nontreponemal, All
- GNAAntisera, All Types, Escherichia Coli
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- CEKBiuret (Colorimetric), Total Protein
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- ICLCarbol Fuchsin
- JFJCatalytic Methods, Amylase
- JJHClinical Sample Concentrator
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- DPMColumns, Liquid Chromatography
- CICCresolphthalein Complexone, Calcium
- ICFCrystal Violet For Histology
- CIGDiazo Colorimetry, Bilirubin
- GIFDiluent, Blood Cell
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- ICCEosin B
- HYBEosin Y
- BSNFilter, Conduction, Anesthetic
- FPBFilter, Infusion Line
- IGNFluid, Bouin'S
- IGGFormaldehyde (Formalin, Formol)
- HYFGiemsa Stain
- HYHGold Chloride
- HYJHematoxylin
- HYKHematoxylin Harris'S
- CFRHexokinase, Glucose
- HYIIodine, Grams
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- HZAMethyl Green
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- HZFNuclear Fast Red
- HZHOrange G
- JCCPh Buffer
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- FIBProtector, Transducer, Dialysis
- CIJSaccharogenic, Amylase
- HZSSafranin
- IGBSolution, Formalin-Sodium Acetate
- JCESolution, Isotonic
- IAMSolution, Lugol'S
- HZJStain, Papanicolau
- FIPSubsystem, Water Purification
- DHRSystem, Test, Rheumatoid Factor
- IABToluidine Blue
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1185-2024 | Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap. | This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink. | Class II | Open, Classified | |
| Z-0408-2024 | Lugol s Iodine Solution 500ML, Part Number 624-71 | Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles. | Class II | Open, Classified | |
| Z-0043-2012 | Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology. | Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens. | Terminated | ||
| Z-1044-2010 | Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS. | Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter. | Terminated | ||
| Z-0954-2009 | LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit. | Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. | Terminated | ||
| Z-0953-2009 | LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet | Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. | Terminated | ||
| Z-2303-2008 | Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests. | Two complaints that kit was not performing properly with positive controls. | Terminated | ||
| Z-1607-2008 | EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic. | Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard. | Terminated | ||
| Z-0133-2008 | Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles | Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run. | Terminated | ||
| Z-0499-2007 | Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany | Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present | Terminated | ||
| Z-0498-2007 | Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928 | Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present. | Terminated | ||
| Z-0305-2007 | Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests. | Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly. | Terminated | ||
| Z-0577-04 | Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS | Lack of assurance of sterility | Terminated | ||
| Z-0576-04 | Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS | Lack of assurance of sterility | Terminated | ||
| Z-0575-04 | Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS | Lack of assurance of sterility | Terminated | ||
| Z-0574-04 | Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile Catalog Number: SLHAM33SS | Lack of assurance of sterility | Terminated | ||
| Z-0573-04 | Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS | Lack of assurance of sterility | Terminated | ||
| Z-0685-03 | Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86. | Difficulty in reading slides due to the stain is much greener than normal. | Terminated | ||
| Z-0684-03 | Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 | The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL. | Terminated | ||
| Z-0683-03 | Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. | The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain