Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Gull Laboratories with 57 510(k) clearances. The most recent is a 510(k) clearance dated Feb 26, 1999: HSV 1+2 IGG ELISA TEST.
| Feb 26, 1999 | HSV 1+2 IGG ELISA TESTK983541 · LGC | 510(k) clearances |
| Nov 4, 1997 | MUMPS IGG ELISA TESTYK971857 · LJY | 510(k) clearances |
| Mar 24, 1997 | TOXO IGG ELISA TESTK962343 · LGD | 510(k) clearances |
| Sep 19, 1995 | EBNA IGG ELISA TESTK935730 · LLM | 510(k) clearances |
| Sep 15, 1995 | EBV-EA(D) IGG ELISA TESTK940093 · LSE | 510(k) clearances |
| Aug 24, 1995 | VZV IGG ELISA TESTK941046 · LFY | 510(k) clearances |
| Aug 23, 1995 | EBV LGG ELISA TESTK941198 · LSE | 510(k) clearances |
| Aug 15, 1995 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSORK932333 · EFB | 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
