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Bio-Rad Laboratories, Inc.

82 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661)Bio-Rad Laboratories, Inc.2019-02-13
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664)Bio-Rad Laboratories, Inc.2017-09-13
D-10 Hemoglobin A1c Program (K161687)Bio-Rad Laboratories, Inc.2016-10-14
D-100 HbA1c, D-100 HbA1c Calibrator Pack (K151321)Bio-Rad Laboratories, Inc.2015-12-09
VARIANT II TURBO HbA1c Kit - 2.0 (K142448)Bio-Rad Laboratories, Inc.2015-03-24
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM (K140801)Bio-Rad Laboratories, Inc.2014-06-25
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (K130053)Bio-Rad Laboratories, Inc.2013-09-19
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963)Bio-Rad Laboratories, Inc.2013-05-06
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504)Bio-Rad Laboratories, Inc.2012-03-27
BIOPLEX 2200 TORC IGG (K120572)Bio-Rad Laboratories, Inc.2012-03-26
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
MONOLISA ANTI-HAV EIA (K092355)Bio-Rad Laboratories, Inc.2009-10-29
MONOLISA ANTI-HAV IGM EIA (K092353)Bio-Rad Laboratories, Inc.2009-10-29
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 (K090699)Bio-Rad Laboratories, Inc.2009-07-27
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI (K090737)Bio-Rad Laboratories, Inc.2009-06-03
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET (K080008)Bio-Rad Laboratories, Inc.2009-02-23
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU (K070452)Bio-Rad Laboratories, Inc.2007-05-07
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211)Bio-Rad Laboratories, Inc.2006-12-08
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213)Bio-Rad Laboratories, Inc.2006-12-08
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 (K063400)Bio-Rad Laboratories, Inc.2006-12-01
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM (K060001)Bio-Rad Laboratories, Inc.2006-01-20
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341)Bio-Rad Laboratories, Inc.2005-10-27
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM (K051072)Bio-Rad Laboratories, Inc.2005-05-12
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) (K050682)Bio-Rad Laboratories, Inc.2005-04-29
LIQUICHEK BNP CONTROL (K043584)Bio-Rad Laboratories, Inc.2005-02-08
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 (K041658)Bio-Rad Laboratories, Inc.2004-12-20
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL (K043108)Bio-Rad Laboratories, Inc.2004-12-07
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446)Bio-Rad Laboratories, Inc.2004-11-02
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK (K042336)Bio-Rad Laboratories, Inc.2004-10-14
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 (K042335)Bio-Rad Laboratories, Inc.2004-09-17
BIO-RAD D-10 DUAL PROGRAM (K041444)Bio-Rad Laboratories, Inc.2004-06-09
LIQUICHEK TORCH PLUS IGM CONTROL (K040822)Bio-Rad Laboratories, Inc.2004-05-19
VARIANT II HEMOGLOBIN A1C (K040872)Bio-Rad Laboratories, Inc.2004-04-15
LIQUICHEK CARDIAC MARKER CONTROL LT (K040277)Bio-Rad Laboratories, Inc.2004-03-10
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273)Bio-Rad Laboratories, Inc.2004-03-04
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924)Bio-Rad Laboratories, Inc.2004-02-03
D-10 HEMOGLOBIN A1C (K031043)Bio-Rad Laboratories, Inc.2003-08-27
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 (K022041)Bio-Rad Laboratories, Inc.2002-07-16
LIQUICHEK URINE CHEMISTRY CONTROL (K020817)Bio-Rad Laboratories, Inc.2002-04-12
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
ACCESS CHLAMYDIA ASSAY (K960850)Bio-Rad Laboratories, Inc.1997-02-04
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 (K963934)Bio-Rad Laboratories, Inc.1996-12-16
ACCESS RUBELLA IGG (K954687)Bio-Rad Laboratories, Inc.1996-04-09
ACCESS FREE T3 ASSAY (K960913)Bio-Rad Laboratories, Inc.1996-03-29
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
ACCESS VITAMIN B12 ASSAY (MODIFICATION) (K955436)Bio-Rad Laboratories, Inc.1996-01-24
ACCESS TOTAL T3 ASSAY (MODIFICATION) (K955435)Bio-Rad Laboratories, Inc.1996-01-24
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM (K951495)Bio-Rad Laboratories, Inc.1995-12-20
ACCESS CORTISOL ASSAY (MODIFICATION) (K954733)Bio-Rad Laboratories, Inc.1995-12-05
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K954825)Bio-Rad Laboratories, Inc.1995-11-21
ACCESS TOTAL BHCG ASSAY (MODIFICATION) (K954732)Bio-Rad Laboratories, Inc.1995-11-20
ACCESS ALLERGEN DOG EPITHELIM (K953780)Bio-Rad Laboratories, Inc.1995-11-14
ACCESS LOW LEVEL IGE CONTROLS (K953883)Bio-Rad Laboratories, Inc.1995-11-14
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
ACCESS MYOGLOBIN REAGENTS (K951634)Bio-Rad Laboratories, Inc.1995-09-27
ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084)Bio-Rad Laboratories, Inc.1995-09-25
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR (K950629)Bio-Rad Laboratories, Inc.1995-05-23
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807)Bio-Rad Laboratories, Inc.1995-05-19
ACCESS CK-MB REAGENTS (K945083)Bio-Rad Laboratories, Inc.1994-11-21
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393)Bio-Rad Laboratories, Inc.1994-09-20
ACCESS(R) TOTAL T3 (K940833)Bio-Rad Laboratories, Inc.1994-09-07
ACCESS PROLACTIN (K941175)Bio-Rad Laboratories, Inc.1994-06-02
ACCESS CORTISOL REAGENTS (K940221)Bio-Rad Laboratories, Inc.1994-04-26
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY (K940549)Bio-Rad Laboratories, Inc.1994-04-06
ACCESS SPECIFIC IGE ASSAY (K935876)Bio-Rad Laboratories, Inc.1994-03-11
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY (K940005)Bio-Rad Laboratories, Inc.1994-03-03
ACCESS VITAMIN B12 ASSAY (K933142)Bio-Rad Laboratories, Inc.1993-11-05
ACCESS(R) THYROXINE ASSAY (K926475)Bio-Rad Laboratories, Inc.1993-06-15
ACCESS(R) TOTAL IGE ASSAY (K930984)Bio-Rad Laboratories, Inc.1993-06-09
ACCESS THYROID UPTAKE ASSAY (K930010)Bio-Rad Laboratories, Inc.1993-06-07
ACCESS(R) CORTISOL REAGENTS (K926322)Bio-Rad Laboratories, Inc.1993-05-26
ACCESS HTSH ASSAY (K925637)Bio-Rad Laboratories, Inc.1993-03-01
EXPRESSO CARTRIDGE (K923316)Bio-Rad Laboratories, Inc.1993-02-23
KALLESTAD RSV MICROPLATE EIA (K924289)Bio-Rad Laboratories, Inc.1993-02-12
ACCESS TOTAL BHCG ASSAY (K926198)Bio-Rad Laboratories, Inc.1993-02-08
ACCESS(R) FREE T4 ASSAY (K925913)Bio-Rad Laboratories, Inc.1993-01-27
ACCESS DIGOXIN ASSAY (K925802)Bio-Rad Laboratories, Inc.1993-01-13
ACCESS FERRITIN ASSAY (K926221)Bio-Rad Laboratories, Inc.1993-01-13
KALESTAD ANA MICROPLATE EIA (K924087)Bio-Rad Laboratories, Inc.1992-11-02
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823)Bio-Rad Laboratories, Inc.1992-08-05
KALLESTAD ROTAVIRUS MICROPLATE (K915137)Bio-Rad Laboratories, Inc.1992-03-04
KALLESTEAD TOTAL IGE MICROPLATE KIT (K912800)Bio-Rad Laboratories, Inc.1991-07-25

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