Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of WerfenLabelled 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 Chromogenix with 4 510(k) clearances. The most recent is a 510(k) clearance dated Dec 23, 1996: COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S.
| Date | Record | Source |
|---|---|---|
| Dec 23, 1996 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SK963111 · GGW | 510(k) clearances |
| Jan 23, 1996 | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAYK952515 · JBQ | 510(k) clearances |
| Nov 20, 1995 | COACUTE HEPARINK952514 · KFF | 510(k) clearances |
| Dec 7, 1992 | COAMATE PROTEIN C CHROMOGENIC ASSAYK922201 · GGP | 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
