Medical Device Manufacturer · US , Elkhart , IN

Gds Diagnostics - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1989

Recent clearances: ACETASITE, CONTROL AND LINEARITY, GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gds Diagnostics Chemistry ✕

3 devices

1-3 of 3

Cleared Sep 13, 1991

CONTROL AND LINEARITY

Chemistry · 196d

Cleared Mar 04, 1991

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

Chemistry · 53d

Cleared May 16, 1989

GDS ENZYMATIC THEOPHYLLINE REAGENT

Chemistry · 53d