# Wellcome Diagnostics

- Location (FDA's records): Research Triangle Pk, NC
- FDA decisions: 28 (1983–1992): 28 510(k) clearances
- Product codes: GTJ (5), GTZ (3), LIQ (2), JHI (1), KFF (1), GWC (1), GTN (1), GRD (1), JCO (1), GNB (1), JBQ (1), JJX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Cepheid: 2 (https://510kreport.com/company/cepheid)
- Binax, Inc.: 2 (https://510kreport.com/company/binax)
- Bd Diagnostics (Geneohm Sciences Canada, Inc): 1 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences-canada)
- Microphage, Inc.: 1 (https://510kreport.com/company/microphage)

## Its most-cited devices
- K851949: Staphaurex ZL30 (1985), cited by 4
- K854852: Wellcogen Bacterial Antigen Kit (1986), cited by 2

## Recent decisions
- K915203: D-Dimer Wellcotest (HA10) (Jan 31, 1992)
- K910797: Streptex Acid Extraction Kit (Mar 29, 1991)
- K895461: Wellcolex Colour Shigella Test ZC51 (Jan 11, 1990)
- K890146: Wellcolex Colour Salmonella Test ZL 50 (Feb 16, 1989)
- K875311: Wellcozyme HSV WZO2 (Aug 3, 1988)
- K861628: Wellcozyme Rotavirus WZ01 (Jan 21, 1987)
- K864206: Reveal Colour Strep a ZL16 (Jan 13, 1987)
- K861634: The Wellcome Rotavirus Latex Test ZL40 (Oct 29, 1986)

Source page: https://510kreport.com/company/wellcome-diagnostics