Company ยท US
Gds Technology, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2002. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2002 | K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 Gds Technology | KHG |
| Jan 14, 2000 | K994073 | HEMOSITE TEST SYSTEM Gds Technology, LLC | KHG |
| Aug 20, 1999 | K992132 | CHOLESITE TEST SYSTEM Gds Technology, LLC | CHH |
| Aug 31, 1998 | K973649 | HEMOSITE TEST SYSTEM Gds Technology, LLC | KHG |
| Sep 17, 1997 | K971145 | GLUCOSITE TEST SYSTEM Gds Technology, LLC | CGA |
| Jul 1, 1991 | K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON Gds Technology, LLC | JIN |
| Jun 24, 1988 | K882038 | GDS ENZYMATIC SALICYLATE REAGENT Gds Technology, LLC | DKJ |
| May 27, 1988 | K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT Gds Technology, LLC | LDP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||