Medical Device Manufacturer · US , Waltham , MA

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

6 submissions · 6 cleared · Since 2001

Recent clearances: SMARTCHECK INR SYSTEM, ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY, ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

6

Total

6

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared Nov 30, 2007

SMARTCHECK INR SYSTEM

Hematology · 207d