Medical device 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 Elias U.S.A. with 54 510(k) clearances. The most recent is a 510(k) clearance dated Mar 6, 1997: ELIAS ANA-HEP-2.
| Mar 6, 1997 | ELIAS ANA-HEP-2K964385 · LJM | 510(k) clearances |
| Sep 30, 1996 | VARELISA ANA (4) PROFILEK963291 · LJM | 510(k) clearances |
| Aug 30, 1996 | VARELISA HELICOBACTER PYLORI ANTIBODIESK953873 · LYR | 510(k) clearances |
| Jan 26, 1996 | VARELISA MPO-ANCAK953587 · MOB | 510(k) clearances |
| Jan 26, 1996 | VARELISA PR3-ANCAK953586 · MOB | 510(k) clearances |
| Oct 2, 1995 | VARELISA CARDIOLIPIN ABS SCREENK951187 · MID | 510(k) clearances |
| Apr 17, 1995 | VARELISA PARIETAL CELL ANTIBODIESK951206 · MLE | 510(k) clearances |
| Apr 17, 1995 | VARELISA ANA PROFILEK951205 · LJM | 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
