Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

134 results for "Bio-Rad Laboratories"
25–48 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
Cleared May 09, 2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
K130990 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 29d
Cleared May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Apr 25, 2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM...
K130860 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 28d
Cleared Apr 12, 2013
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761 · JJY
Bio-Rad Laboratories
Immunology · 23d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · JJY
Bio-Rad Laboratories
Chemistry · 37d
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL...
K123775 · JJY
Bio-Rad Laboratories
Chemistry · 52d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798 · JJX
Bio-Rad Laboratories
Chemistry · 30d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK...
K123198 · JJY
Bio-Rad Laboratories
Chemistry · 40d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021 · LJN
Bio-Rad Laboratories
Microbiology · 36d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 73d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY...
K122838 · JJY
Bio-Rad Laboratories
Chemistry · 30d
Cleared Jul 09, 2012
ANA-SCREEN WITH MDSS
K113610 · LKJ
Bio-Rad Laboratories
Immunology · 216d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · MXJ
Bio-Rad Laboratories
Microbiology · 84d
Cleared May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · DIF
Bio-Rad Laboratories
Chemistry · 32d
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · MID
Bio-Rad Laboratories
Immunology · 456d
Cleared Mar 27, 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE...
K120504 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · NHX
Bio-Rad Laboratories
Immunology · 29d
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K111072 · OPL
Bio-Rad Laboratories
Microbiology · 127d
Cleared Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
K092587 · LFX
Bio-Rad Laboratories
Microbiology · 466d
Cleared Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · NHX
Bio-Rad Laboratories
Immunology · 244d
Cleared Aug 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
K091303 · JPK
Bio-Rad Laboratories
Hematology · 455d