Search FDA 510(k) Database

Cleared Mar 29, 2010

BIOPLEX 2200 MMRV IGG

K091616 · OPL

Bio-Rad Laboratories

Microbiology · 299d

Cleared Mar 12, 2010

LIQUICHEK OPIATE CONTROL

K093577 · DIF

Bio-Rad Laboratories

Chemistry · 114d

Cleared Oct 29, 2009

MONOLISA ANTI-HAV EIA

K092355 · LOL

Bio-Rad Laboratories, Inc.

Microbiology · 86d

Cleared Oct 29, 2009

MONOLISA ANTI-HAV IGM EIA

K092353 · LOL

Bio-Rad Laboratories, Inc.

Microbiology · 86d

Cleared Jul 27, 2009

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS...

K090699 · LCP

Bio-Rad Laboratories, Inc.

Chemistry · 132d

Cleared Jul 01, 2009

PLATELIA TOXO IGM KIT MODEL 26211

K090847 · LGD

Bio-Rad Laboratories

Microbiology · 93d

Cleared Jun 03, 2009

HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY...

K090737 · JKA

Bio-Rad Laboratories, Inc.

Chemistry · 75d

Cleared May 08, 2009

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...

K090409 · MXJ

Bio-Rad Laboratories

Microbiology · 79d

Cleared Feb 23, 2009

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

K080008 · OMI

Bio-Rad Laboratories, Inc.

Microbiology · 418d

Cleared Sep 08, 2008

LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK

K082036 · JJY

Bio-Rad Laboratories

Immunology · 53d

Cleared May 02, 2008

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING...

K080911 · GKA

Bio-Rad Laboratories Inc., Clinical...

Hematology · 30d

Cleared Jan 24, 2008

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K073080 · JJY

Bio-Rad Laboratories

Chemistry · 85d

Cleared Oct 31, 2007

BIOPLEX VASCULITIS KIT

K072358 · MVJ

Bio-Rad Laboratories

Immunology · 70d

Cleared Jul 03, 2007

LIQUICHEK TUMOR MARKER CONTROL

K071675 · JJY

Bio-Rad Laboratories

Immunology · 14d

Cleared Jun 25, 2007

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK...

K070819 · LCP

Bio-Rad Laboratories Inc., Clinical...

Chemistry · 91d

Cleared May 07, 2007

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

K070452 · LCP

Bio-Rad Laboratories, Inc.

Chemistry · 80d

Cleared May 03, 2007

MONOLISA ANTI-HAV IGM EIA

K063319 · LOL

Bio-Rad Laboratories

Microbiology · 182d

Cleared May 03, 2007

MONOLISA ANTI-HAV EIA

K063318 · LOL

Bio-Rad Laboratories

Microbiology · 182d

Cleared Apr 02, 2007

LYPHOCHEK DIABETES CONTROL

K070546 · GGM

Bio-Rad Laboratories

Chemistry · 35d

Cleared Mar 19, 2007

BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K063866 · LIP

Bio-Rad Laboratories

Microbiology · 80d

Cleared Dec 27, 2006

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT...

K063643 · LCP

Bio-Rad Laboratories Inc., Clinical...

Chemistry · 20d

Cleared Dec 08, 2006

BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K062213 · LSE

Bio-Rad Laboratories, Inc.

Microbiology · 129d

Cleared Dec 08, 2006

BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K062211 · LSE

Bio-Rad Laboratories, Inc.

Microbiology · 129d

Cleared Dec 01, 2006

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

K063400 · LCP

Bio-Rad Laboratories, Inc.

Chemistry · 22d