Medical Device Manufacturer · US , New York , NY

Enzo Biochem, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1987

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enzo Biochem, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Aug 03, 1988

COLORGENE HSV DNA HYBRIDIZATION TEST

Microbiology · 173d

Cleared Mar 28, 1988

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

Microbiology · 88d

Cleared Dec 04, 1987

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

Microbiology · 157d

Cleared May 26, 1987

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

Microbiology · 90d