Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
96 devices
Cleared
Aug 12, 1998
MICROALBUSTIX REAGENT STRIPS
Chemistry
49d
Cleared
Jun 05, 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Chemistry
56d
Cleared
Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Immunology
83d
Cleared
Apr 02, 1998
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
Toxicology
64d
Cleared
Mar 03, 1998
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
Chemistry
75d
Cleared
Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Chemistry
73d
Cleared
Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Immunology
374d
Cleared
Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Immunology
385d
Cleared
Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Microbiology
146d
Cleared
Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Immunology
83d
Cleared
Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Chemistry
74d
Cleared
Sep 09, 1997
CLINITEK MICROALBUMIN REAGENT STRIPS
Chemistry
50d
Cleared
Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
Hematology
91d
Cleared
Jun 27, 1997
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Chemistry
49d
Cleared
Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
Chemistry
70d
Cleared
Jun 11, 1997
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Toxicology
33d
Cleared
May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
Immunology
181d
Cleared
Apr 04, 1997
CLINITEK HCG TEST STRIPS
Chemistry
2d
Cleared
Feb 10, 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
Chemistry
126d
Cleared
Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
Chemistry
83d
Cleared
Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
Chemistry
140d
Cleared
Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
Toxicology
59d
Cleared
Dec 24, 1996
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Chemistry
70d
Cleared
Dec 18, 1996
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Chemistry
42d
Cleared
Dec 13, 1996
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Toxicology
64d
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