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"
265–288 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 23d
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769 · JLS
Bio-Rad Laboratories, Inc.
Chemistry · 46d
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · DIF
Bio-Rad
Toxicology · 84d
Cleared Jan 30, 1996
BENZODIAZEPINES BY REMEDI HS
K955116 · LAA
Bio-Rad
Toxicology · 82d
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 28, 1995
LIQUICHEK ETHANOL/AMMONIA CONTROL
K955024 · JJY
Bio-Rad
Chemistry · 26d
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 20, 1995
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · GKA
Bio-Rad
Hematology · 84d
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 Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · KLI
Bio-Rad
Chemistry · 154d
Cleared Aug 01, 1995
BIO-RAD URINARY 5-HIAA BY HPLC
K952817 · CDA
Bio-Rad
Chemistry · 42d
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 May 16, 1995
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
K945651 · JJY
Bio-Rad
Immunology · 180d
Cleared Apr 14, 1995
VARIANT TOTAL GHB PROGRAM
K941616 · LCP
Bio-Rad
Hematology · 375d
Cleared Mar 27, 1995
REMEDI HS DRUG PROFILING SYSTEM
K941596 · DNI
Bio-Rad
Toxicology · 360d