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"
97–120 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769 · JLS
Bio-Rad Laboratories, Inc.
Chemistry · 46d
Cleared Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · LGD
Bio-Rad Laboratories, Inc.
Microbiology · 264d
Cleared Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
K954733 · CGR
Bio-Rad Laboratories, Inc.
Chemistry · 64d
Cleared Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 32d
Cleared Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 49d
Cleared Nov 14, 1995
ACCESS LOW LEVEL IGE CONTROLS
K953883 · JJX
Bio-Rad Laboratories, Inc.
Immunology · 88d
Cleared Nov 14, 1995
ACCESS ALLERGEN DOG EPITHELIM
K953780 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Oct 20, 1995
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 18d
Cleared Sep 27, 1995
ACCESS MYOGLOBIN REAGENTS
K951634 · DDR
Bio-Rad Laboratories, Inc.
Chemistry · 173d
Cleared Sep 25, 1995
ACCESS ULTRASENSITIVE INSULIN ASSAY
K953084 · CFP
Bio-Rad Laboratories, Inc.
Chemistry · 84d
Cleared May 23, 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND...
K950629 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 99d
Cleared May 19, 1995
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 533d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083 · JHS
Bio-Rad Laboratories, Inc.
Chemistry · 35d
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 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 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 Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 130d
Cleared Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
K926475 · KLI
Bio-Rad Laboratories, Inc.
Chemistry · 168d