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 13, 2026, FDA's public records list Elan Diagnostics with 13 510(k) clearances. The most recent is a 510(k) clearance dated Sep 29, 2003: ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR.
| Date | Record | Source |
|---|---|---|
| Sep 29, 2003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030003 · CIG | 510(k) clearances |
| Sep 26, 2003 | ATAC TOTAL BILIRUBIN REAGENTK030014 · CIG | 510(k) clearances |
| Mar 19, 2003 | ATAC CALIBRATORK030621 · JIX | 510(k) clearances |
| Mar 13, 2003 | ATAC CALCIUM REAGENT AND ATAC CALIBRATORK023105 · CIC | 510(k) clearances |
| Mar 10, 2003 | ATAC PAK MAGNESIUM REAGENTK030010 · JGJ | 510(k) clearances |
| Mar 7, 2003 | ATAC PAK PHOSPHORUS REAGENTK030015 · CEO | 510(k) clearances |
| Mar 7, 2003 | ATAC PAK ALBUMIN REAGENTK030006 · CIX | 510(k) clearances |
| Feb 14, 2003 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATORK023407 · CGX | 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
