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 Cogent Diagnostics with 31 510(k) clearances. The most recent is a 510(k) clearance dated Oct 13, 2000: AUTOSTAT II ENA-4 PROFILE ELISA.
| Oct 13, 2000 | AUTOSTAT II ENA-4 PROFILE ELISAK003057 · LLL | 510(k) clearances |
| Oct 13, 2000 | AUTOSTAT II ENA-6 PROFILE ELISAK003054 · LLL | 510(k) clearances |
| Sep 28, 2000 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK002215 · MOB | 510(k) clearances |
| Mar 3, 2000 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK993557 · DHR | 510(k) clearances |
| Feb 3, 2000 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISAK994338 · DHR | 510(k) clearances |
| Feb 1, 2000 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISAK993085 · MID | 510(k) clearances |
| Dec 6, 1999 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISAK993304 · DHR | 510(k) clearances |
| Nov 24, 1999 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISAK992449 · MID | 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
