Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
41 devices
Cleared
Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
Toxicology
159d
Cleared
Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
Toxicology
39d
Cleared
Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
Toxicology
39d
Cleared
Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
Toxicology
39d
Cleared
Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
Toxicology
63d
Cleared
Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
Toxicology
23d
Cleared
Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
Toxicology
90d
Cleared
Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
Toxicology
48d
Cleared
Jul 15, 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
Toxicology
28d
Cleared
Dec 22, 1980
QUANTIMUNE E3 RIA
Toxicology
33d
Cleared
Jan 23, 1980
FLUOROMATIC PHENOLBARBITAL FIA
Toxicology
9d
Cleared
Jan 11, 1980
FLUOROMATIC PHENYTOIN FIA
Toxicology
15d
Cleared
Oct 17, 1979
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
Toxicology
63d
Cleared
Oct 17, 1979
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
Toxicology
40d
Cleared
Oct 12, 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
Toxicology
63d
Cleared
Sep 04, 1979
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO
Toxicology
27d