Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
159 devices
Cleared
Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
Chemistry
306d
Cleared
Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
Chemistry
14d
Cleared
Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
Chemistry
20d
Cleared
Oct 28, 1996
RADIAS GALT TEST
Chemistry
196d
Cleared
Oct 01, 1996
MANUAL PHENYLALANINE TEST
Chemistry
57d
Cleared
Sep 16, 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
Chemistry
119d
Cleared
Aug 16, 1996
RADIAS PHENYLALANINE TEST
Chemistry
198d
Cleared
Jul 08, 1996
CDM
Chemistry
161d
Cleared
Jun 11, 1996
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
Chemistry
29d
Cleared
Nov 28, 1995
LIQUICHEK ETHANOL/AMMONIA CONTROL
Chemistry
26d
Cleared
Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
Chemistry
154d
Cleared
Aug 01, 1995
BIO-RAD URINARY 5-HIAA BY HPLC
Chemistry
42d
Cleared
Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
Chemistry
65d
Cleared
Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
Chemistry
158d
Cleared
Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
Chemistry
405d
Cleared
Nov 10, 1994
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
Chemistry
171d
Cleared
Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
Chemistry
161d
Cleared
Feb 18, 1994
QUANTAPHASE II B12/FOLATE
Chemistry
137d
Cleared
Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
Chemistry
43d
Cleared
Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
Chemistry
70d
Cleared
Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
Chemistry
49d
Cleared
Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
Chemistry
131d
Cleared
Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
Chemistry
35d
Cleared
Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
Chemistry
61d
Cleared
May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
Chemistry
78d
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