Gds Technology, LLC

Medical device manufacturer in Elkhart, IN.

8510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K020138Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special 02/11/2002SE
K994073Hemosite Test SystemKHG · Traditional 01/14/2000SE
K992132Cholesite Test SystemCHH · Traditional 08/20/1999SE
K973649Hemosite Test SystemKHG · Traditional 08/31/1998SE
K971145Glucosite Test SystemCGA · Traditional 09/17/1997SE
K911801Ketosite(Tm)/Stat-Site(Tm)/Ketosite(Tm) Low-Hi ConJIN · Traditional 07/01/1991SE
K882038GDS Enzymatic Salicylate ReagentDKJ · Traditional 06/24/1988SE
K880829GDS Enzymatic Acetaminophen ReagentLDP · Traditional 05/27/1988SE