Medical device 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 13, 2026, FDA's public records list DMS Products with 6 510(k) clearances. The most recent is a 510(k) clearance dated Nov 9, 1989: RAPIDEC STAPH.
| Nov 9, 1989 | RAPIDEC STAPHK891004 · LQL | 510(k) clearances |
| Sep 26, 1989 | RAPIDEC URK894805 · JXA | 510(k) clearances |
| Jun 2, 1989 | RAPIDEC COLIK890626 · JSS | 510(k) clearances |
| Feb 17, 1989 | JAMES REAGENTK890625 · JTO | 510(k) clearances |
| Mar 6, 1986 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)K854733 · JSS | 510(k) clearances |
| Mar 4, 1986 | API 50 CHB (CULTURE MEDIA)K854732 · JST | 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
