Medical Device Manufacturer · US , Palisades Park , NJ

Sentech Korea Corp. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sentech Korea Corp. Toxicology ✕

2 devices

1-2 of 2

Cleared May 11, 2006

BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000

Toxicology · 90d

Cleared Jan 20, 2006

BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500

Toxicology · 50d