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"
313–336 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · CHP
Bio-Rad
Chemistry · 131d
Cleared Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317 · JJY
Bio-Rad
Chemistry · 35d
Cleared Aug 03, 1993
BIO-PEN SRK II CALCULATOR
K922590 · LQB
Bio-Rad
Ophthalmic · 427d
Cleared Jul 08, 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · DIF
Bio-Rad
Toxicology · 36d
Cleared Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K932076 · JJY
Bio-Rad
Chemistry · 61d
Cleared Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
K921443 · HKX
Bio-Rad
Ophthalmic · 483d
Cleared Jun 16, 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · JLW
Bio-Rad
Toxicology · 107d
Cleared Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
K926475 · KLI
Bio-Rad Laboratories, Inc.
Chemistry · 168d
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 May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · CEC
Bio-Rad
Chemistry · 78d
Cleared Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
K930898 · JJI
Bio-Rad
Chemistry · 58d
Cleared Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · LCP
Bio-Rad
Hematology · 91d
Cleared Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · JPD
Bio-Rad
Hematology · 209d
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 14, 1993
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · GKA
Bio-Rad
Hematology · 111d
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 Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · JJT
Bio-Rad
Chemistry · 65d