Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled 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 Wellcome Diagnostics with 28 510(k) clearances. The most recent is a 510(k) clearance dated Jan 31, 1992: D-DIMER WELLCOTEST (HA10).
| Date | Record | Source |
|---|---|---|
| Jan 31, 1992 | D-DIMER WELLCOTEST (HA10)K915203 · DAP | 510(k) clearances |
| Mar 29, 1991 | STREPTEX ACID EXTRACTION KITK910797 · GTZ | 510(k) clearances |
| Jan 11, 1990 | WELLCOLEX COLOUR SHIGELLA TEST ZC51K895461 · GNB | 510(k) clearances |
| Feb 16, 1989 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50K890146 · GRM | 510(k) clearances |
| Aug 3, 1988 | WELLCOZYME HSV WZO2K875311 · GQN | 510(k) clearances |
| Jan 21, 1987 | WELLCOZYME ROTAVIRUS WZ01K861628 · LIQ | 510(k) clearances |
| Jan 13, 1987 | REVEAL COLOUR STREP A ZL16K864206 · GTZ | 510(k) clearances |
| Oct 29, 1986 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40K861634 · LIQ | 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
