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"
289–312 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Mar 20, 1995
BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
K941994 · LFI
Bio-Rad
Toxicology · 329d
Cleared Mar 20, 1995
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
K941990 · LFI
Bio-Rad
Toxicology · 329d
Cleared Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · KLI
Bio-Rad
Chemistry · 65d
Cleared Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · CGN
Bio-Rad
Chemistry · 158d
Cleared Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · JLW
Bio-Rad
Chemistry · 405d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083 · JHS
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Nov 10, 1994
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · LDM
Bio-Rad
Chemistry · 171d
Cleared Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 316d
Cleared Sep 07, 1994
ACCESS(R) TOTAL T3
K940833 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 196d
Cleared Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · LJM
Bio-Rad
Immunology · 93d
Cleared Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
K942209 · JCN
Bio-Rad
Hematology · 42d
Cleared Jun 02, 1994
ACCESS PROLACTIN
K941175 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Apr 26, 1994
ACCESS CORTISOL REAGENTS
K940221 · CGR
Bio-Rad Laboratories, Inc.
Toxicology · 98d
Cleared Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · CEP
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · JLW
Bio-Rad
Chemistry · 161d
Cleared Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · LCP
Bio-Rad
Hematology · 134d
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Mar 03, 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005 · CGJ
Bio-Rad Laboratories, Inc.
Chemistry · 59d
Cleared Feb 18, 1994
QUANTAPHASE II B12/FOLATE
K935286 · CGN
Bio-Rad
Chemistry · 137d
Cleared Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 130d
Cleared Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
K934357 · JJY
Bio-Rad
Chemistry · 43d
Cleared Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · CGN
Bio-Rad
Chemistry · 70d
Cleared Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · DEW
Bio-Rad
Immunology · 63d
Cleared Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · CDD
Bio-Rad
Chemistry · 49d