Medical Device Manufacturer · US , Thorofare , NJ

Akers Biosciences, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2005

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Akers Biosciences, Inc. Toxicology ✕

3 devices

1-3 of 3

Cleared Jan 12, 2011

Toxicology · 147d

Cleared Dec 18, 2006

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS

Toxicology · 80d

Cleared Apr 28, 2006

BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS

Toxicology · 38d