Gds Technology, LLC
Elkhart, IN, US
Gds Technology, LLC appears in FDA device records in Elkhart, IN. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Gds Technology, LLC between 1988 and 2002. The busiest year on record is 1988, with 2. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1991 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | KHG | Substantially Equivalent | |
| K994073 | HEMOSITE TEST SYSTEM | KHG | Substantially Equivalent | |
| K992132 | CHOLESITE TEST SYSTEM | CHH | Substantially Equivalent | |
| K973649 | HEMOSITE TEST SYSTEM | KHG | Substantially Equivalent | |
| K971145 | GLUCOSITE TEST SYSTEM | CGA | Substantially Equivalent | |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | JIN | Substantially Equivalent | |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | DKJ | Substantially Equivalent | |
| K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | LDP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain