Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
96 devices
Cleared
Sep 27, 1996
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC...
Chemistry
50d
Cleared
Sep 27, 1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
Chemistry
45d
Cleared
Aug 30, 1996
RETICULOCYTE METHOD
Hematology
331d
Cleared
Aug 23, 1996
RETICULOCYTE METHOD, RBC INDICES
Hematology
325d
Cleared
Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Immunology
58d
Cleared
Aug 02, 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
Microbiology
226d
Cleared
Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
Chemistry
60d
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 18, 1996
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
Toxicology
67d
Cleared
Jun 13, 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS...
Hematology
219d
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
Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
Microbiology
385d
Cleared
Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Chemistry
128d
Cleared
Nov 13, 1995
QUINTEST
General Hospital
90d
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
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