Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
60 devices
Cleared
Jul 12, 1996
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO...
Chemistry
24d
Cleared
Jul 05, 1996
CHEK-STIX U.T.I. SELF-TEST
Chemistry
123d
Cleared
Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
Chemistry
125d
Cleared
Jun 03, 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL...
Chemistry
59d
Cleared
Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Chemistry
128d
Cleared
Jul 14, 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
Chemistry
102d
Cleared
Jun 13, 1995
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
Chemistry
41d
Cleared
Jun 09, 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
Chemistry
63d
Cleared
May 02, 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
Chemistry
36d
Cleared
Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
Chemistry
52d