Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
60 devices
Cleared
Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Chemistry
56d
Cleared
Jul 09, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST...
Chemistry
130d
Cleared
Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
Chemistry
79d
Cleared
Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Chemistry
55d
Cleared
May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
Chemistry
106d
Cleared
Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
Chemistry
128d
Cleared
Jan 29, 1999
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Chemistry
211d
Cleared
Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
Chemistry
75d
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
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
Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Chemistry
74d
Cleared
Sep 09, 1997
CLINITEK MICROALBUMIN REAGENT STRIPS
Chemistry
50d
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
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
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
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 02, 1996
TECHNICON IMMUNO 1 SYSTEM
Chemistry
60d