Medical Device Manufacturer · US , Cambridge , MA

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

6 submissions · 6 cleared · Since 1992

6

Total

6

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Dec 13, 1996

Toxicology · 88d

Cleared Apr 21, 1993

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

Toxicology · 49d

Cleared Feb 24, 1992

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

Toxicology · 238d