Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list GDS Technology with 8 510(k) clearances. The most recent is a 510(k) clearance dated Feb 11, 2002: STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-….
| Date | Record | Source |
|---|---|---|
| Feb 11, 2002 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090K020138 · KHG | 510(k) clearances |
| Jan 14, 2000 | HEMOSITE TEST SYSTEMK994073 · KHG | 510(k) clearances |
| Aug 20, 1999 | CHOLESITE TEST SYSTEMK992132 · CHH | 510(k) clearances |
| Aug 31, 1998 | HEMOSITE TEST SYSTEMK973649 · KHG | 510(k) clearances |
| Sep 17, 1997 | GLUCOSITE TEST SYSTEMK971145 · CGA | 510(k) clearances |
| Jul 1, 1991 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONK911801 · JIN | 510(k) clearances |
| Jun 24, 1988 | GDS ENZYMATIC SALICYLATE REAGENTK882038 · DKJ | 510(k) clearances |
| May 27, 1988 | GDS ENZYMATIC ACETAMINOPHEN REAGENTK880829 · LDP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
