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"
97–120 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Feb 08, 2005
LIQUICHEK BNP CONTROL
K043584 · JJX
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · JJY
Bio-Rad
Chemistry · 49d
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K041658 · LKJ
Bio-Rad Laboratories, Inc.
Immunology · 185d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 28d
Cleared Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · DIF
Bio-Rad
Chemistry · 37d
Cleared Nov 05, 2004
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · JPK
Bio-Rad
Hematology · 22d
Cleared Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · JJY
Bio-Rad
Immunology · 24d
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837 · JJX
Bio-Rad
Chemistry · 19d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · JJW
Bio-Rad Laboratories, Inc.
Chemistry · 54d
Cleared Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · JPK
Bio-Rad Laboratories, Inc.
Hematology · 45d
Cleared Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · JJY
Bio-Rad
Chemistry · 41d
Cleared Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 18d
Cleared Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · DIF
Bio-Rad
Chemistry · 26d
Cleared Jun 28, 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · JPK
Bio-Rad
Hematology · 27d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · JJY
Bio-Rad Laboratories, Inc.
Microbiology · 50d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 13d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 34d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · GGN
Bio-Rad
Hematology · 22d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 47d
Cleared Dec 12, 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404 · DIF
Bio-Rad
Toxicology · 49d
Cleared Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · DIF
Bio-Rad
Toxicology · 52d
Cleared Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K033387 · JJY
Bio-Rad
Chemistry · 40d