Medical Device Manufacturer · US , Elkhart , IN

Bayer Group Diagnostics - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2002

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Group Diagnostics Chemistry ✕

2 devices

1-2 of 2

Cleared Apr 30, 2002

GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)

Chemistry · 98d

Cleared Apr 29, 2002

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

Chemistry · 97d