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"
73–96 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Oct 31, 2007
BIOPLEX VASCULITIS KIT
K072358 · MVJ
Bio-Rad Laboratories
Immunology · 70d
Cleared Sep 13, 2007
MRSASELECT
K070361 · JSO
Bio-Rad
Microbiology · 218d
Cleared Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675 · JJY
Bio-Rad Laboratories
Immunology · 14d
Cleared Jun 26, 2007
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS...
K071319 · GGN
Bio-Rad, Diagnostics Grp.
Hematology · 47d
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 25, 2007
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK,...
K070848 · JJW
Bio-Rad, Diagnostics Grp.
Chemistry · 28d
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
Cleared Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
K060641 · NOM
Bio-Rad
Microbiology · 84d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 17d
Cleared Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · GGM
Bio-Rad
Chemistry · 33d
Cleared Oct 27, 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH...
K043341 · NVI
Bio-Rad Laboratories, Inc.
Immunology · 328d
Cleared Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · DIF
Bio-Rad
Toxicology · 11d
Cleared May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 16d
Cleared Apr 29, 2005
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · DIF
Bio-Rad Laboratories, Inc.
Toxicology · 44d
Cleared Apr 27, 2005
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS...
K050537 · JJY
Bio-Rad
Chemistry · 56d
Cleared Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536 · JJY
Bio-Rad
Chemistry · 22d