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 Organon. FDA records under 2 spellings of its name, each linked to the record. See the Organon group view.
As of Nov 15, 2026, FDA's public records list Organon Teknika with 130 510(k) clearances and 1 device recall. The most recent is a device recall dated Jan 11, 2019: Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 11, 2019 | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226,Class II · This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false | Device recalls |
| Oct 20, 2000 | BACT/ALERT CSRK003104 · LJF | 510(k) clearances |
| Jun 7, 2000 | MDA D-DIMERK000492 · DAP | 510(k) clearances |
| Mar 2, 2000 | BACT/ALERT MB CULTURE BOTTLEK000378 · MDB | 510(k) clearances |
| Feb 10, 2000 | BACT/ALERT SVK994343 · MDB | 510(k) clearances |
| Dec 15, 1999 | BACT/ALERT SAK993423 · MDB | 510(k) clearances |
| Dec 14, 1999 | BACT/ALERT SNK993421 · MDB | 510(k) clearances |
| Dec 14, 1999 | BACT/ALERT MP PROCESS BOTTLEK993576 · MDB | 510(k) clearances |
| Sep 24, 1999 | BACT/ALERT FNK992432 · MDB | 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
