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Bio-Rad Laboratories

FDA 510(k) & PMA Approved Devices — 37 products

Total Devices37
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K183446 BioPlex 2200 Lyme TotalLSR2019-03-12 View
510(k) K180577 BioPlex 2200 25-OH Vitamin D KitMRG2018-06-22 View
510(k) K170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetPUQ2017-05-19 View
510(k) K170413 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetLIP2017-05-11 View
510(k) K163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakJJY2017-01-10 View
510(k) K152679 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakPMN2016-05-10 View
510(k) K132227 LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYJJY2013-10-25 View
510(k) K130528 BIOPLEX 2200 APLS IGMMID2013-10-21 View
510(k) K130761 LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAKJJY2013-04-12 View
510(k) K130162 LIQUID ASSAYED MULTIQUAL PREMIUMJJY2013-03-01 View
510(k) K123775 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAKJJY2013-01-31 View
510(k) K123798 LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAKJJX2013-01-09 View
510(k) K123663 LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAKJJY2012-12-27 View
510(k) K123198 LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHAJJY2012-11-20 View
510(k) K123021 BIOPLEX 2200 EBV IGM KITLJN2012-11-02 View
510(k) K122838 LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEKJJY2012-10-17 View
510(k) K113610 ANA-SCREEN WITH MDSSLKJ2012-07-09 View
510(k) K120959 BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITMXJ2012-06-22 View
510(k) K121143 LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)DIF2012-05-18 View
510(k) K103834 BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSMID2012-03-30 View
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