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Bio-Rad Laboratories

46 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
BioPlex 2200 Lyme Total (K183446)Bio-Rad Laboratories2019-03-12
BioPlex 2200 25-OH Vitamin D Kit (K180577)Bio-Rad Laboratories2018-06-22
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (K170509)Bio-Rad Laboratories2017-05-19
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413)Bio-Rad Laboratories2017-05-11
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015)Bio-Rad Laboratories2017-01-10
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak (K152679)Bio-Rad Laboratories2016-05-10
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak (DEN150058)Bio-Rad Laboratories2016-03-28
Liquichek Cardiac Markers Plus Control LT (K150300)Bio-Rad Laboratories2015-12-11
Liquichek Maternal Serum II Control (K143379)Bio-Rad Laboratories2015-03-13
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D (K141114)Bio-Rad Laboratories2015-01-09
LIQUICHEK TUMOR MARKER CONTROL (K141073)Bio-Rad Laboratories2014-06-23
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK (K140916)Bio-Rad Laboratories2014-05-06
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK (K140764)Bio-Rad Laboratories2014-04-25
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO (K134013)Bio-Rad Laboratories2014-04-24
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL (K133960)Bio-Rad Laboratories2014-01-22
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY (K132227)Bio-Rad Laboratories2013-10-25
BIOPLEX 2200 APLS IGM (K130528)Bio-Rad Laboratories2013-10-21
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK (K130761)Bio-Rad Laboratories2013-04-12
LIQUID ASSAYED MULTIQUAL PREMIUM (K130162)Bio-Rad Laboratories2013-03-01
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK (K123775)Bio-Rad Laboratories2013-01-31
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123798)Bio-Rad Laboratories2013-01-09
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123663)Bio-Rad Laboratories2012-12-27
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA (K123198)Bio-Rad Laboratories2012-11-20
BIOPLEX 2200 EBV IGM KIT (K123021)Bio-Rad Laboratories2012-11-02
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK (K122838)Bio-Rad Laboratories2012-10-17
ANA-SCREEN WITH MDSS (K113610)Bio-Rad Laboratories2012-07-09
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959)Bio-Rad Laboratories2012-06-22
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143)Bio-Rad Laboratories2012-05-18
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (K103834)Bio-Rad Laboratories2012-03-30
MULTI-ANALYTE DETECTION SYSTEMS (K112810)Bio-Rad Laboratories2011-10-26
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (K111072)Bio-Rad Laboratories2011-08-23
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587)Bio-Rad Laboratories2010-12-03
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K093954)Bio-Rad Laboratories2010-08-24
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV (K091303)Bio-Rad Laboratories2010-08-02
BIOPLEX 2200 MMRV IGG (K091616)Bio-Rad Laboratories2010-03-29
LIQUICHEK OPIATE CONTROL (K093577)Bio-Rad Laboratories2010-03-12
PLATELIA TOXO IGM KIT MODEL 26211 (K090847)Bio-Rad Laboratories2009-07-01
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K090409)Bio-Rad Laboratories2009-05-08
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (K082036)Bio-Rad Laboratories2008-09-08
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K073080)Bio-Rad Laboratories2008-01-24
BIOPLEX VASCULITIS KIT (K072358)Bio-Rad Laboratories2007-10-31
LIQUICHEK TUMOR MARKER CONTROL (K071675)Bio-Rad Laboratories2007-07-03
MONOLISA ANTI-HAV EIA (K063318)Bio-Rad Laboratories2007-05-03
MONOLISA ANTI-HAV IGM EIA (K063319)Bio-Rad Laboratories2007-05-03
LYPHOCHEK DIABETES CONTROL (K070546)Bio-Rad Laboratories2007-04-02
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K063866)Bio-Rad Laboratories2007-03-19

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Every clearance here is in the API, with alerts when new ones post.