Atlas FDA

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

Bio-Rad Laboratories — Predicate Candidate Screening

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

87 daysmedian FDA review time
299 days90th percentile
46clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K183446BioPlex 2200 Lyme TotalBio-Rad Laboratories2019-03-12900
K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories2018-06-221090
K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set,Bio-Rad Laboratories2017-05-19870
K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis TotBio-Rad Laboratories2017-05-11900
K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor MarkBio-Rad Laboratories2017-01-10740
K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, LBio-Rad Laboratories2016-05-102350
DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, ABio-Rad Laboratories2016-03-281030
K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories2015-12-113080
K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories2015-03-131080
K141114BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VBio-Rad Laboratories2015-01-092540
K141073LIQUICHEK TUMOR MARKER CONTROLBio-Rad Laboratories2014-06-23590
K140916LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEBio-Rad Laboratories2014-05-06260
K140764LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPABio-Rad Laboratories2014-04-25290
K134013LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGENBio-Rad Laboratories2014-04-241150
K133960LYPOCHEK SPECIALTY IMMUNOASSAY CONTROLBio-Rad Laboratories2014-01-22290
K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMBio-Rad Laboratories2013-10-251000
K130528BIOPLEX 2200 APLS IGMBio-Rad Laboratories2013-10-212341
K130761LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAKBio-Rad Laboratories2013-04-12230
K130162LIQUID ASSAYED MULTIQUAL PREMIUMBio-Rad Laboratories2013-03-01370
K123775LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUBio-Rad Laboratories2013-01-31520
K123798LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILBio-Rad Laboratories2013-01-09300
K123663LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL Bio-Rad Laboratories2012-12-27290
K123198LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHBio-Rad Laboratories2012-11-20400
K123021BIOPLEX 2200 EBV IGM KITBio-Rad Laboratories2012-11-02360
K122838LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUIBio-Rad Laboratories2012-10-17300
K113610ANA-SCREEN WITH MDSSBio-Rad Laboratories2012-07-092160
K120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories2012-06-22840
K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2Bio-Rad Laboratories2012-05-18320
K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROLBio-Rad Laboratories2012-03-304560
K112810MULTI-ANALYTE DETECTION SYSTEMSBio-Rad Laboratories2011-10-26292
K111072BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECBio-Rad Laboratories2011-08-231270
K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTIBio-Rad Laboratories2010-12-034660
K093954BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE Bio-Rad Laboratories2010-08-242442
K091303LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LVBio-Rad Laboratories2010-08-024550
K091616BIOPLEX 2200 MMRV IGGBio-Rad Laboratories2010-03-292990
K093577LIQUICHEK OPIATE CONTROLBio-Rad Laboratories2010-03-121140
K090847PLATELIA TOXO IGM KIT MODEL 26211Bio-Rad Laboratories2009-07-01931
K090409BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ABio-Rad Laboratories2009-05-08790
K082036LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINBio-Rad Laboratories2008-09-08530
K073080QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 94Bio-Rad Laboratories2008-01-24850
K072358BIOPLEX VASCULITIS KITBio-Rad Laboratories2007-10-31700
K071675LIQUICHEK TUMOR MARKER CONTROLBio-Rad Laboratories2007-07-03140
K063318MONOLISA ANTI-HAV EIABio-Rad Laboratories2007-05-031820
K063319MONOLISA ANTI-HAV IGM EIABio-Rad Laboratories2007-05-031820
K070546LYPHOCHEK DIABETES CONTROLBio-Rad Laboratories2007-04-02350
K063866BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALBio-Rad Laboratories2007-03-19802

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