Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bio-Rad Laboratories, Inc. — Predicate Candidate Screening

82 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
231 days90th percentile
82clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc.2019-02-132331
K171664Hemoglobin Variants System on Newborn Hemoglobin System withBio-Rad Laboratories, Inc.2017-09-131000
K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc.2016-10-141190
K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.2015-12-092050
K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc.2015-03-242030
K140801VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEMBio-Rad Laboratories, Inc.2014-06-25860
K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSBio-Rad Laboratories, Inc.2013-09-192470
K130963LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC COBio-Rad Laboratories, Inc.2013-05-06280
K120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUIBio-Rad Laboratories, Inc.2012-03-27350
K120572BIOPLEX 2200 TORC IGGBio-Rad Laboratories, Inc.2012-03-26280
K120439BIOPLEX 2200 EBV IGG AND SYPHILIS IGGBio-Rad Laboratories, Inc.2012-03-14300
K092355MONOLISA ANTI-HAV EIABio-Rad Laboratories, Inc.2009-10-29860
K092353MONOLISA ANTI-HAV IGM EIABio-Rad Laboratories, Inc.2009-10-29861
K090699VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION Bio-Rad Laboratories, Inc.2009-07-271320
K090737HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGBio-Rad Laboratories, Inc.2009-06-03750
K080008BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROLBio-Rad Laboratories, Inc.2009-02-234180
K070452VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NUBio-Rad Laboratories, Inc.2007-05-07801
K062211BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DEBio-Rad Laboratories, Inc.2006-12-081292
K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETBio-Rad Laboratories, Inc.2006-12-081291
K063400VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING Bio-Rad Laboratories, Inc.2006-12-01224
K060001D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAMBio-Rad Laboratories, Inc.2006-01-20171
K043341BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWABio-Rad Laboratories, Inc.2005-10-273282
K051072BIO-RAD VARIANT NBS SICKLE CELL PROGRAMBio-Rad Laboratories, Inc.2005-05-12160
K050682LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)Bio-Rad Laboratories, Inc.2005-04-29440
K043584LIQUICHEK BNP CONTROLBio-Rad Laboratories, Inc.2005-02-08420
K041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETBio-Rad Laboratories, Inc.2004-12-201850
K043108LIQUICHEK SPECIALTY IMMUNOASSAY CONTROLBio-Rad Laboratories, Inc.2004-12-07280
K042446QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLSBio-Rad Laboratories, Inc.2004-11-02540
K042336METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVBio-Rad Laboratories, Inc.2004-10-14450
K042335ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITBio-Rad Laboratories, Inc.2004-09-17180
K041444BIO-RAD D-10 DUAL PROGRAMBio-Rad Laboratories, Inc.2004-06-0982
K040822LIQUICHEK TORCH PLUS IGM CONTROLBio-Rad Laboratories, Inc.2004-05-19501
K040872VARIANT II HEMOGLOBIN A1CBio-Rad Laboratories, Inc.2004-04-15134
K040277LIQUICHEK CARDIAC MARKER CONTROL LTBio-Rad Laboratories, Inc.2004-03-10340
K040273LYPHOCHEK ASSAYED CHEMISTRY CONTROLBio-Rad Laboratories, Inc.2004-03-04282
K033924LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)Bio-Rad Laboratories, Inc.2004-02-03470
K031043D-10 HEMOGLOBIN A1CBio-Rad Laboratories, Inc.2003-08-271486
K022041LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563Bio-Rad Laboratories, Inc.2002-07-16220
K020817LIQUICHEK URINE CHEMISTRY CONTROLBio-Rad Laboratories, Inc.2002-04-12300
K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBio-Rad Laboratories, Inc.1997-02-25420
K960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.1997-02-043400
K963934ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZEBio-Rad Laboratories, Inc.1996-12-16760
K954687ACCESS RUBELLA IGGBio-Rad Laboratories, Inc.1996-04-091810
K960913ACCESS FREE T3 ASSAYBio-Rad Laboratories, Inc.1996-03-29231
K955769ACCESS PROGESTERONE ASSAYBio-Rad Laboratories, Inc.1996-02-05462
K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.1996-01-241141
K955435ACCESS TOTAL T3 ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.1996-01-241141
K951495ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEMBio-Rad Laboratories, Inc.1995-12-202640
K954733ACCESS CORTISOL ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.1995-12-05641
K954825ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAYBio-Rad Laboratories, Inc.1995-11-21320

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda