Medical Device Manufacturer · US , Englewood , NJ

Serex, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1989

5

Total

5

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Aug 24, 1992

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

Toxicology · 48d

Cleared Jun 15, 1992

AUTOMATES COMA COCAINE METABOLITE ASSAY

Toxicology · 60d

Cleared Nov 08, 1989

COMA COCAINE METABOLITE ASSAY (EIA)

Toxicology · 91d