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"
49–72 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
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