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"
73–96 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 17d
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 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 Feb 08, 2005
LIQUICHEK BNP CONTROL
K043584 · JJX
Bio-Rad Laboratories, Inc.
Chemistry · 42d
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 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 Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 18d
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 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 47d
Cleared Aug 27, 2003
D-10 HEMOGLOBIN A1C
K031043 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 148d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · CHP
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 340d
Cleared Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS:...
K963934 · MMI
Bio-Rad Laboratories, Inc.
Chemistry · 76d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · LFX
Bio-Rad Laboratories, Inc.
Microbiology · 181d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 23d