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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

460 results for "Bio-Rad"
49–72 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K111072 · OPL
Bio-Rad Laboratories
Microbiology · 127d
Cleared Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · NOM
Bio-Rad
Microbiology · 412d
Cleared Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
K092587 · LFX
Bio-Rad Laboratories
Microbiology · 466d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO
Bio-Rad
Microbiology · 241d
Cleared Sep 14, 2010
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED...
K100727 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 183d
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
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 Jun 26, 2008
PLATELIA LYME IGM
K081362 · LSR
Bio-Rad
Microbiology · 42d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO
Bio-Rad
Microbiology · 45d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · LSR
Bio-Rad
Microbiology · 126d
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 Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
K072835 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 69d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · DIF
Bio-Rad, Diagnostics Grp.
Chemistry · 76d