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 15, 2026, FDA's public records list Medical Diagnostic Technologies with 57 510(k) clearances. The most recent is a 510(k) clearance dated Sep 11, 2006: CTC WORKSTATION, MODEL 2200.
| Sep 11, 2006 | CTC WORKSTATION, MODEL 2200K062229 · LLZ | 510(k) clearances |
| Aug 12, 1997 | SPECTROLYSE HEPARIN (ANTI-IIA)K972209 · KFF | 510(k) clearances |
| Nov 18, 1996 | CHROMOLIZE PAI-1 KITK963106 · GGP | 510(k) clearances |
| Aug 14, 1996 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K960871 · JBQ | 510(k) clearances |
| Jul 31, 1996 | CHROMOLIZE TPA ASSAY KITK962489 · GGP | 510(k) clearances |
| Jun 5, 1996 | TINTELIZE PAI-1 KITK960438 · GGP | 510(k) clearances |
| Jun 3, 1996 | U-DOA CONTROLSK961724 · DIF | 510(k) clearances |
| May 24, 1996 | LA POSITIVE CONTROL PLASMAK961370 · GGC | 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
