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Bio-Rad Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 79 products

Total Devices79
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX2019-02-13 View
510(k) K171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA2017-09-13 View
510(k) K161687 D-10 Hemoglobin A1c ProgramPDJ2016-10-14 View
510(k) K130053 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIMVM2013-09-19 View
510(k) K130963 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAKJJY2013-05-06 View
510(k) K120504 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKDIF2012-03-27 View
510(k) K120572 BIOPLEX 2200 TORC IGGOMI2012-03-26 View
510(k) K120439 BIOPLEX 2200 EBV IGG AND SYPHILIS IGGLIP2012-03-14 View
510(k) K092353 MONOLISA ANTI-HAV IGM EIALOL2009-10-29 View
510(k) K092355 MONOLISA ANTI-HAV EIALOL2009-10-29 View
510(k) K090699 VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730LCP2009-07-27 View
510(k) K090737 HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBIJKA2009-06-03 View
510(k) K080008 BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SETOMI2009-02-23 View
510(k) K070452 VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NULCP2007-05-07 View
510(k) K062211 BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMLSE2006-12-08 View
510(k) K062213 BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMLSE2006-12-08 View
510(k) K063400 VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0LCP2006-12-01 View
510(k) K060001 D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAMLCP2006-01-20 View
510(k) K043341 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMNVI2005-10-27 View
510(k) K051072 BIO-RAD VARIANT NBS SICKLE CELL PROGRAMGKA2005-05-12 View
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