FDA 510(k) Applications Submitted by BIO-RAD LABORATORIES, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K960850 03/01/1996 ACCESS CHLAMYDIA ASSAY BIO-RAD LABORATORIES, INC.
K954687 10/11/1995 ACCESS RUBELLA IGG BIO-RAD LABORATORIES, INC.
K041658 06/18/2004 BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 BIO-RAD LABORATORIES, INC.
K043341 12/03/2004 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC.
K080008 01/02/2008 BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET BIO-RAD LABORATORIES, INC.
K062211 08/01/2006 BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC.
K062213 08/01/2006 BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC.
K955435 10/02/1995 ACCESS TOTAL T3 ASSAY (MODIFICATION) BIO-RAD LABORATORIES, INC.
K955436 10/02/1995 ACCESS VITAMIN B12 ASSAY (MODIFICATION) BIO-RAD LABORATORIES, INC.
K960913 03/06/1996 ACCESS FREE T3 ASSAY BIO-RAD LABORATORIES, INC.
K955769 12/21/1995 ACCESS PROGESTERONE ASSAY BIO-RAD LABORATORIES, INC.
K140801 03/31/2014 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM BIO-RAD LABORATORIES, INC.
K040273 02/05/2004 LYPHOCHEK ASSAYED CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC.
K120504 02/21/2012 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK BIO-RAD LABORATORIES, INC.
K020817 03/13/2002 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC.
K050682 03/16/2005 LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) BIO-RAD LABORATORIES, INC.
K033924 12/18/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) BIO-RAD LABORATORIES, INC.
K060001 01/03/2006 D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM BIO-RAD LABORATORIES, INC.
K031043 04/01/2003 D-10 HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC.
K040872 04/02/2004 VARIANT II HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC.
K151321 05/18/2015 D-100 HbA1c, D-100 HbA1c Calibrator Pack Bio-Rad Laboratories, Inc.
K041444 06/01/2004 BIO-RAD D-10 DUAL PROGRAM BIO-RAD LABORATORIES, INC.
K161687 06/17/2016 D-10 Hemoglobin A1c Program BIO-RAD LABORATORIES, INC.
K142448 09/02/2014 VARIANT II TURBO HbA1c Kit - 2.0 Bio-Rad Laboratories, Inc.
K063400 11/09/2006 VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 BIO-RAD LABORATORIES, INC.
K070452 02/16/2007 VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU BIO-RAD LABORATORIES, INC.
K090699 03/17/2009 VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 BIO-RAD LABORATORIES, INC.
K963934 10/01/1996 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 BIO-RAD LABORATORIES, INC.
K090737 03/20/2009 HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI BIO-RAD LABORATORIES, INC.
K130053 01/15/2013 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI BIO-RAD LABORATORIES, INC.
K120439 02/13/2012 BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC.
K120572 02/27/2012 BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC.
K092353 08/04/2009 MONOLISA ANTI-HAV IGM EIA BIO-RAD LABORATORIES, INC.
K092355 08/04/2009 MONOLISA ANTI-HAV EIA BIO-RAD LABORATORIES, INC.
K040822 03/30/2004 LIQUICHEK TORCH PLUS IGM CONTROL BIO-RAD LABORATORIES, INC.
K040277 02/05/2004 LIQUICHEK CARDIAC MARKER CONTROL LT BIO-RAD LABORATORIES, INC.
K022041 06/24/2002 LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 BIO-RAD LABORATORIES, INC.
K042336 08/30/2004 METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK BIO-RAD LABORATORIES, INC.
K042335 08/30/2004 ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 BIO-RAD LABORATORIES, INC.
K042446 09/09/2004 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC.
K970126 01/14/1997 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) BIO-RAD LABORATORIES, INC.
K181661 06/25/2018 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System Bio-Rad Laboratories, Inc.
K130963 04/08/2013 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK BIO-RAD LABORATORIES, INC.
K043108 11/09/2004 LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES, INC.
K043584 12/28/2004 LIQUICHEK BNP CONTROL BIO-RAD LABORATORIES, INC.
K171664 06/05/2017 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software Bio-Rad Laboratories, Inc.
K051072 04/26/2005 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM BIO-RAD LABORATORIES, INC.


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