FirmLabelled 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 14, 2026, FDA's public records list Breit Laboratories with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 25, 1985: IGM RHEUMATOID FACTOR TEST KIT.
| Apr 25, 1985 | IGM RHEUMATOID FACTOR TEST KITK851099 · DHR | 510(k) clearances |
| Sep 5, 1984 | OCCULT BLOOD TESTK842137 · KHE | 510(k) clearances |
| Sep 5, 1984 | COLOTRAK OCCULT BLOOD TESTK840527 · KHE | 510(k) clearances |
| Aug 11, 1983 | ANTI-N DNA ANTIBODY TEST KITK832031 · KTL | 510(k) clearances |
| Jul 18, 1983 | ANTINUCLEAR ANTIBODY TEST KITK831927 · DAA | 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