Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
319 devices
Cleared
Jan 05, 1988
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
Chemistry
137d
Cleared
Dec 22, 1987
HVA & HOMOVANILLIC ACID BY HPLC METHOD
Chemistry
120d
Cleared
Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
Hematology
90d
Cleared
Jul 06, 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
Chemistry
27d
Cleared
May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
Microbiology
16d
Cleared
Feb 20, 1987
DIGILAB MODEL 1500 PERIMETER
Ophthalmic
39d
Cleared
Feb 20, 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
Ophthalmic
39d
Cleared
Jan 09, 1987
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
Immunology
17d
Cleared
Nov 07, 1986
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
Immunology
17d
Cleared
Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
Immunology
22d
Cleared
Sep 24, 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
Ophthalmic
35d
Cleared
Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
Hematology
84d
Cleared
Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
Toxicology
90d
Cleared
Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
Chemistry
56d
Cleared
Jul 01, 1986
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
Hematology
22d
Cleared
May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
Chemistry
44d
Cleared
Apr 11, 1986
ECHOCLONAL HTSH IRMA
Immunology
73d
Cleared
Mar 28, 1986
BIOGRAM APO A1/B
Immunology
37d
Cleared
Feb 27, 1986
DIGILAB CAMBRIDGE PERIMETER
Ophthalmic
45d
Cleared
Jul 30, 1985
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
Hematology
102d
Cleared
Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
Toxicology
48d
Cleared
Jun 28, 1985
ECHOCLONAL HCG IRMA
Chemistry
38d
Cleared
Mar 04, 1985
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
Ophthalmic
45d
Cleared
Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
Chemistry
77d
Cleared
Sep 26, 1984
TRIGLYCERIDES GPO REAGENT
Chemistry
16d
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