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 13, 2026, FDA's public records list Lerner Laboratories with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 22, 1985: XYLENE SUBSTITUTE MONTANT.
| Oct 22, 1985 | XYLENE SUBSTITUTE MONTANTK854083 · KEM | 510(k) clearances |
| Oct 22, 1985 | XYLENE SUBSTITUTEK853694 · KEM | 510(k) clearances |
| Jun 2, 1982 | FORMICALK821443 · KDX | 510(k) clearances |
| Dec 6, 1976 | PAP-TRAY II (CATALOG #C600-2)K761001 · LEA | 510(k) clearances |
| Dec 6, 1976 | PAP-TRAY I (CATALOG #C600-1)K761000 · LEA | 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
