Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Corp. Chemistry ✕
60 devices
Cleared
Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
Chemistry
84d
Cleared
Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
Chemistry
77d
Cleared
Jan 23, 2003
ASCENSIA GLUCOFACTS
Chemistry
31d
Cleared
Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
Chemistry
26d
Cleared
Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
Chemistry
63d
Cleared
Dec 06, 2001
BAYER ADVIA IMS SYSTEM
Chemistry
135d
Cleared
Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
Chemistry
151d
Cleared
Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
Chemistry
24d
Cleared
Oct 01, 2001
BAYER ADVIA SYSTEM
Chemistry
69d
Cleared
Sep 12, 2001
GLUCOMETER DEX TEST SENSOR
Chemistry
58d
Cleared
Mar 29, 2001
BAYER ADVIA IMS SYSTEM
Chemistry
66d
Cleared
Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
Chemistry
109d
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