Medical Device Manufacturer · US , Cambridge , MA

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

6 submissions · 6 cleared · Since 1992

Recent clearances: NICCHECK I, MYCOAKT M. AVIUM CULTURE ID KIT, MYCOAKT M KANSASII CULTURE ID KIT

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Mar 13, 1995

MYCOAKT M. AVIUM CULTURE ID KIT

Microbiology · 259d

Cleared Mar 13, 1995

MYCOAKT M KANSASII CULTURE ID KIT

Microbiology · 259d

Cleared Mar 13, 1995

MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT

Microbiology · 259d