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 Agen Biomedical with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 14, 1999: SIMPLIFY D-DIMER, MODEL DCGK1.
| Dec 14, 1999 | SIMPLIFY D-DIMER, MODEL DCGK1K993276 · GHH | 510(k) clearances |
| May 26, 1998 | DIMERTEST LATEX ASSAYK974596 · DAP | 510(k) clearances |
| Oct 25, 1995 | AGEN DIMERTEST GOLD EIAK945642 · GHH | 510(k) clearances |
| Apr 12, 1991 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYK905643 · GHH | 510(k) clearances |
| Mar 3, 1989 | AGEN DIMERTEST EIAK890189 · DAP | 510(k) clearances |
| Aug 17, 1988 | DIMERTEST(R) LATEXK882944 · DAP | 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
