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"
121–134 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
Cleared Jun 09, 1993
ACCESS(R) TOTAL IGE ASSAY
K930984 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 104d
Cleared Jun 07, 1993
ACCESS THYROID UPTAKE ASSAY
K930010 · CEE
Bio-Rad Laboratories, Inc.
Chemistry · 154d
Cleared May 26, 1993
ACCESS(R) CORTISOL REAGENTS
K926322 · JFT
Bio-Rad Laboratories, Inc.
Chemistry · 161d
Cleared Mar 01, 1993
ACCESS HTSH ASSAY
K925637 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 112d
Cleared Feb 23, 1993
EXPRESSO CARTRIDGE
K923316 · JQP
Bio-Rad Laboratories, Inc.
Chemistry · 231d
Cleared Feb 12, 1993
KALLESTAD RSV MICROPLATE EIA
K924289 · MCE
Bio-Rad Laboratories, Inc.
Microbiology · 175d
Cleared Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
K926198 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 61d
Cleared Jan 27, 1993
ACCESS(R) FREE T4 ASSAY
K925913 · CEC
Bio-Rad Laboratories, Inc.
Toxicology · 65d
Cleared Jan 13, 1993
ACCESS FERRITIN ASSAY
K926221 · JMG
Bio-Rad Laboratories, Inc.
Immunology · 34d
Cleared Jan 13, 1993
ACCESS DIGOXIN ASSAY
K925802 · KXT
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Nov 02, 1992
KALESTAD ANA MICROPLATE EIA
K924087 · LJM
Bio-Rad Laboratories, Inc.
Immunology · 81d
Cleared Aug 05, 1992
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
K922823 · CGN
Bio-Rad Laboratories, Inc.
Chemistry · 55d
Cleared Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · LIQ
Bio-Rad Laboratories, Inc.
Microbiology · 112d
Cleared Jul 25, 1991
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 30d