Gds Diagnostics

Medical device manufacturer in Elkhart, IN.

4510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K931257AcetasiteLDP · Traditional 07/08/1993SE
K910881Control and LinearityDKB · Traditional 09/13/1991SE
K910108GDS Enzymatic B-Hydroxybutyrate Reagent ModifiedJIN · Traditional 03/04/1991SE
K891761GDS Enzymatic Theophylline ReagentLCY · Traditional 05/16/1989SE