Bio-Rad Laboratories, Inc. - FDA 510(k) Cleared Devices
82
Total
82
Cleared
0
Denied
46 devices
Cleared
Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
Chemistry
114d
Cleared
Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
Chemistry
64d
Cleared
Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Chemistry
32d
Cleared
Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
Chemistry
49d
Cleared
Oct 20, 1995
ACCESS PROLACTIN ASSAY (MODIFICATION)
Chemistry
18d
Cleared
Sep 27, 1995
ACCESS MYOGLOBIN REAGENTS
Chemistry
173d
Cleared
Sep 25, 1995
ACCESS ULTRASENSITIVE INSULIN ASSAY
Chemistry
84d
Cleared
Nov 21, 1994
ACCESS CK-MB REAGENTS
Chemistry
35d
Cleared
Sep 07, 1994
ACCESS(R) TOTAL T3
Chemistry
196d
Cleared
Jun 02, 1994
ACCESS PROLACTIN
Chemistry
80d
Cleared
Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
Chemistry
58d
Cleared
Mar 03, 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
Chemistry
59d
Cleared
Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
Chemistry
130d
Cleared
Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
Chemistry
168d
Cleared
Jun 07, 1993
ACCESS THYROID UPTAKE ASSAY
Chemistry
154d
Cleared
May 26, 1993
ACCESS(R) CORTISOL REAGENTS
Chemistry
161d
Cleared
Mar 01, 1993
ACCESS HTSH ASSAY
Chemistry
112d
Cleared
Feb 23, 1993
EXPRESSO CARTRIDGE
Chemistry
231d
Cleared
Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
Chemistry
61d
Cleared
Jan 13, 1993
ACCESS DIGOXIN ASSAY
Chemistry
58d
Cleared
Aug 05, 1992
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
Chemistry
55d