Medical Device Manufacturer · US , Waltham , MA

Inverness Medical Innovations, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2001

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Inverness Medical Innovations, Inc. Chemistry ✕

5 devices

1-5 of 5

Cleared Jul 30, 2007

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

Chemistry · 49d

Cleared Feb 16, 2006

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

Chemistry · 29d

Cleared Dec 16, 2005

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)

Chemistry · 30d

Cleared Nov 30, 2001

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA...

Chemistry · 200d

Cleared Jun 21, 2001

INDUO BLOOD GLUCOSE METER

Chemistry · 27d