Search FDA 510(k) Database

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