Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Elite Diagnostic, Ltd. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 21, 1989: EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME.
| Apr 21, 1989 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIMEK890859 · GFO | 510(k) clearances |
| Apr 21, 1989 | EDL ONE-STAGE PROTHROMBIN TIME REAGENTK891370 · GJS | 510(k) clearances |
| Apr 10, 1989 | EDL ABNORMAL COAGULATION CONTROLK891175 · GGL | 510(k) clearances |
| Apr 10, 1989 | EDL NORMAL COAGULATION CONTROLK891179 · GIZ | 510(k) clearances |
| Mar 15, 1989 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENTK890619 · GFO | 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
