Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
159 devices
Cleared
Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
Chemistry
92d
Cleared
Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
Chemistry
93d
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
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
Chemistry
27d
Cleared
Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
Chemistry
56d
Cleared
May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
Chemistry
44d
Cleared
Jun 28, 1985
ECHOCLONAL HCG IRMA
Chemistry
38d
Cleared
Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
Chemistry
77d
Cleared
Sep 26, 1984
TRIGLYCERIDES GPO REAGENT
Chemistry
16d
Cleared
Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
Chemistry
84d
Cleared
Oct 19, 1983
QUANTAPHASE B-12-COBALMIN-FOLATE-
Chemistry
19d
Cleared
Oct 04, 1983
LYPHOCHEK SERUM REF. STANDARD-BOVINE
Chemistry
55d
Cleared
Aug 08, 1983
QUANTIGEN T & B CELL ASSAY
Chemistry
129d
Cleared
Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
Chemistry
48d
Cleared
Jun 22, 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
Chemistry
44d
Cleared
Aug 27, 1982
QUANTIMUNE HTSH IRMA
Chemistry
25d
Cleared
May 28, 1982
QUANTIMUNE HLH RIA
Chemistry
23d
Cleared
Apr 06, 1982
QUANTIMUNE ESTRIOL RIA
Chemistry
20d
Cleared
Jul 10, 1981
QUANTIMUNE ESTRIOL RIA
Chemistry
23d
Cleared
Jul 10, 1981
QUANTAPHASE T-4 RIA
Chemistry
17d
Cleared
Jul 10, 1981
FLUOROMATIC THEOPHYLLINE FIA
Chemistry
9d
Cleared
May 15, 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
Chemistry
17d
Cleared
Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
Chemistry
11d
Cleared
Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
Chemistry
20d
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