# Gds Technology, LLC

- Location (FDA's records): Elkhart, IN
- FDA decisions: 8 (1988–2002): 8 510(k) clearances
- Names in FDA's records: Gds Technology, LLC (7); Gds Technology (1)
- Product codes: KHG (3), CHH (1), DKJ (1), CGA (1), LDP (1), JIN (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coulter Corp.: 1 (https://510kreport.com/company/coulter)

## Firms that cite its devices most
- Medisense, Inc.: 1 (https://510kreport.com/company/medisense)

## Its most-cited devices
- K911801: Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con (1991), cited by 1
- K973649: Hemosite Test System (1998), cited by 1

## Recent decisions
- K020138: Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards, Stat-Site MHGB Code Way, Models 90090 (Feb 11, 2002)
- K994073: Hemosite Test System (Jan 14, 2000)
- K992132: Cholesite Test System (Aug 20, 1999)
- K973649: Hemosite Test System (Aug 31, 1998)
- K971145: Glucosite Test System (Sep 17, 1997)
- K911801: Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con (Jul 1, 1991)
- K882038: GDS Enzymatic Salicylate Reagent (Jun 24, 1988)
- K880829: GDS Enzymatic Acetaminophen Reagent (May 27, 1988)

Source page: https://510kreport.com/company/gds-technology