510(k) Report

FDA applicant

Wellcome Diagnostics

Research Triangle Pk, NC28 decisions1983–19923 recalls

FDA records 28 decisions for Wellcome Diagnostics (Research Triangle Pk, NC) from 1983 to 1992: 28 510(k) clearances. Most are in product codes GTJ (Antisera, All Groups, N. Meningitidis) and GTZ (Antisera, All Groups, Streptococcus Spp.). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Wellcome Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wellcome Diagnostics since 2007.

Recalls per year

1in 2025

2013: 22025: 1
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Wellcome Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GTJAntisera, All Groups, N. Meningitidis5decisions
  • GTZAntisera, All Groups, Streptococcus Spp.3decisions
  • LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus2decisions
  • JHIVisual, Pregnancy Hcg, Prescription Use1decision
  • KFFAssay, Heparin1decision
  • GWCAntisera, All Types, Streptococcus Pneumoniae1decision

Also: GTN (1), GRD (1), JCO (1), GNB (1), JBQ (1), JJX (1).

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K851949Staphaurex ZL30Wellcome Diagnostics · 19854cite it
  • K854852Wellcogen Bacterial Antigen KitWellcome Diagnostics · 19862cite it

What has FDA decided for it lately?

  • K915203D-Dimer Wellcotest (HA10)Wellcome Diagnostics · 1992
  • K910797Streptex Acid Extraction KitWellcome Diagnostics · 1991
  • K895461Wellcolex Colour Shigella Test ZC51Wellcome Diagnostics · 1990
  • K890146Wellcolex Colour Salmonella Test ZL 50Wellcome Diagnostics · 1989
  • K875311Wellcozyme HSV WZO2Wellcome Diagnostics · 1988
  • K861628Wellcozyme Rotavirus WZ01Wellcome Diagnostics · 1987
  • K864206Reveal Colour Strep a ZL16Wellcome Diagnostics · 1987
  • K861634The Wellcome Rotavirus Latex Test ZL40Wellcome Diagnostics · 1986

All 28 as Wellcome Diagnostics →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K840211STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended…Jul 21, 2025Class II
  • K842828Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The…May 2, 2013Class II
  • K842828Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50…May 2, 2013Class II