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 General Biometrics with 23 510(k) clearances. The most recent is a 510(k) clearance dated Dec 1, 1992: IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL.
| Dec 1, 1992 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELK924843 · LLL | 510(k) clearances |
| Aug 20, 1992 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTK920401 · MID | 510(k) clearances |
| Aug 20, 1992 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTK920400 · MID | 510(k) clearances |
| Apr 8, 1992 | IMMUNODOT BORRELIA (LYME) TESTK911627 · LSR | 510(k) clearances |
| Dec 30, 1991 | IMMUNOWELL LYME (P39 RECOMBINANT) TESTK911599 · LSR | 510(k) clearances |
| Dec 20, 1991 | IMMUNOWELL BORRELIA (LYME)TESTK911590 · LSR | 510(k) clearances |
| Dec 9, 1991 | IMMUNOWELL DSDNA ANTIBODY TESTK914801 · DHC | 510(k) clearances |
| May 7, 1991 | IMMUNOWELL RNP/SM ANTIBODY TESTK911848 · LKP | 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
