Diagnostics 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., part of Thermo Fisher ScientificLabelled 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 Thermo Biostar with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 2, 2004: CT OIA.
| Mar 2, 2004 | CT OIAK032330 · LJC | 510(k) clearances |
| Apr 17, 2003 | GC OIAK023947 · LIR | 510(k) clearances |
| Mar 27, 2003 | FLU OIA A/B TEST KITK023556 · PSZ | 510(k) clearances |
| Jan 14, 2003 | RSV OIAK023779 · GQG | 510(k) clearances |
| Sep 13, 2002 | RSV OIAK021172 · GOG | 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
