Medical Device Manufacturer · US , Ann Arbor , MI

Diamond Sensor Systems - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1987

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diamond Sensor Systems Chemistry ✕

2 devices

1-2 of 2

Cleared Jul 28, 1988

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.

Chemistry · 44d

Cleared Apr 28, 1988

GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK

Chemistry · 238d