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"
361–384 of 460
Search insights Median review: 44d Cleared: 100% Top manufacturer: Bio-Rad Lead specialty: Chemistry
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · JJY
Bio-Rad
Toxicology · 104d
Cleared Dec 19, 1989
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K891691 · DIE
Bio-Rad
Toxicology · 272d
Cleared Dec 07, 1989
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · DIF
Bio-Rad
Toxicology · 69d
Cleared Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · HKX
Bio-Rad
Ophthalmic · 47d
Cleared Oct 25, 1989
PLASMA CATECHOLAMINES BY HPLC
K894966 · CHQ
Bio-Rad
Chemistry · 79d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252 · JJY
Bio-Rad
Immunology · 42d
Cleared Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · JJX
Bio-Rad
Chemistry · 138d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · JJY
Bio-Rad
Immunology · 84d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · LAS
Bio-Rad
Chemistry · 24d
Cleared Mar 28, 1989
COTUBE(TM) TSH IRMA
K890802 · JLW
Bio-Rad
Chemistry · 40d
Cleared Dec 22, 1988
COTUBE LH IRMA ASSAY
K884498 · CEP
Bio-Rad
Chemistry · 57d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · JJW
Bio-Rad
Chemistry · 56d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · LIO
Bio-Rad
Microbiology · 20d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · JJY
Bio-Rad
Chemistry · 131d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155 · JHI
Bio-Rad
Chemistry · 80d
Cleared Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · LCP
Bio-Rad
Hematology · 67d
Cleared Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · LCP
Bio-Rad
Hematology · 77d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · JJY
Bio-Rad
Chemistry · 30d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · DIF
Bio-Rad
Toxicology · 159d
Cleared Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · DIF
Bio-Rad
Toxicology · 63d