Medical Device Manufacturer · US , Mishawaka , IN

Bayer Healthcare - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2006

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Healthcare Chemistry ✕

9 devices

1-9 of 9

Cleared Nov 25, 2015

Contour Next USB Blood Glucose Monitoring System

Chemistry · 231d

Cleared Sep 23, 2015

Contour Next Control Solution

Chemistry · 86d

Cleared Sep 26, 2013

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR

Chemistry · 416d

Cleared Jun 28, 2012

CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

Chemistry · 79d

Cleared Mar 28, 2012

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER

Chemistry · 364d

Cleared Mar 06, 2012

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM

Chemistry · 307d

Cleared Aug 26, 2009

CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS

Chemistry · 69d

Cleared Sep 11, 2006

ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151

Chemistry · 53d

Cleared Apr 12, 2006

ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151

Chemistry · 48d