Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
96 devices
Cleared
May 18, 2000
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
Chemistry
58d
Cleared
May 18, 2000
BAYER ADVIA IMS SYSTEM
Chemistry
57d
Cleared
Apr 13, 2000
BAYER PSA ASSAY
Immunology
120d
Cleared
Apr 10, 2000
BAYER ADVIA IMS SYSTEM
Chemistry
147d
Cleared
Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Chemistry
190d
Cleared
Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
Chemistry
56d
Cleared
Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC...
Chemistry
43d
Cleared
Dec 06, 1999
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
Chemistry
63d
Cleared
Dec 06, 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
Chemistry
62d
Cleared
Nov 24, 1999
NEW MULTIPLES REAGENT STRIPS
Chemistry
141d
Cleared
Nov 12, 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
Chemistry
207d
Cleared
Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Immunology
155d
Cleared
Nov 09, 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
Chemistry
138d
Cleared
Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Chemistry
58d
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
May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO...
Immunology
205d
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
Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
Immunology
79d
Cleared
Sep 22, 1998
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Hematology
43d
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