Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
319 devices
Cleared
Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
Chemistry
138d
Cleared
Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
Immunology
42d
Cleared
Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
Immunology
84d
Cleared
Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
Chemistry
24d
Cleared
Mar 28, 1989
COTUBE(TM) TSH IRMA
Chemistry
40d
Cleared
Dec 22, 1988
COTUBE LH IRMA ASSAY
Chemistry
57d
Cleared
Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
Chemistry
56d
Cleared
Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
Microbiology
20d
Cleared
Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
Chemistry
131d
Cleared
Aug 08, 1988
COTUBE HCG IRMA TEST
Chemistry
80d
Cleared
Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
Hematology
77d
Cleared
Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
Hematology
67d
Cleared
Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
Chemistry
30d
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
Mar 16, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
Chemistry
41d
Cleared
Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
Chemistry
40d
Cleared
Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
Chemistry
28d
Cleared
Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
Toxicology
23d
Cleared
Feb 24, 1988
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
Hematology
76d
Cleared
Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
Chemistry
92d
Cleared
Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
Chemistry
93d
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