Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
159 devices
Cleared
Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
Chemistry
58d
Cleared
Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
Chemistry
65d
Cleared
Sep 02, 1992
COTUBE PTH IRMA
Chemistry
128d
Cleared
Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
Chemistry
70d
Cleared
Jun 09, 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
Chemistry
84d
Cleared
Apr 29, 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
Chemistry
54d
Cleared
Jan 09, 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
Chemistry
108d
Cleared
Jan 02, 1992
BIO-RAD TOTAL PROTEIN TEST KIT
Chemistry
161d
Cleared
Sep 07, 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
Chemistry
45d
Cleared
Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
Chemistry
23d
Cleared
Apr 03, 1990
NOVAPATH MICROPLATE READER
Chemistry
42d
Cleared
Mar 09, 1990
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
Chemistry
17d
Cleared
Oct 25, 1989
PLASMA CATECHOLAMINES BY HPLC
Chemistry
79d
Cleared
Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
Chemistry
56d
Cleared
Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
Chemistry
138d
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
Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
Chemistry
131d
Cleared
Aug 08, 1988
COTUBE HCG IRMA TEST
Chemistry
80d
Cleared
Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
Chemistry
30d
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
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