Medical Device Manufacturer · US , Burlington , NJ

Actimed Laboratories, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1996

Recent clearances: ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Actimed Laboratories, Inc. Chemistry ✕

3 devices

1-3 of 3

Cleared Aug 03, 1998

ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)

Chemistry · 124d

Cleared May 02, 1996

ENA-C-T TOTAL CHOLESTEROL TEST

Chemistry · 97d

Cleared Apr 03, 1996

ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS

Chemistry · 68d