510(k) Report

FDA applicant

Wieslab AB

Frederick, MD5 decisions1998–19980 recalls

FDA records 5 decisions for Wieslab AB (Frederick, MD) in 1998: 5 510(k) clearances. Most are in product codes MOB (Test System, Antineutrophil Cytoplasmic…) and DBL (Multiple Autoantibodies, Indirect…). No recall is linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Wieslab AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wieslab AB 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?

  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)4decisions
  • DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K974169Wielisa Anti-GBM Test SystemWieslab AB · 19981cites it

What has FDA decided for it lately?

  • K981750Wielisa Anti-GBM, Anca Screening Kit Test SystemWieslab AB · 1998
  • K981748Wielisa Anca Screening Kit Test SystemWieslab AB · 1998
  • K974167Wielisa PR-3 Anca Test SystemWieslab AB · 1998
  • K974169Wielisa Anti-GBM Test SystemWieslab AB · 1998
  • K974166Wielisa Mpo Anca Test SystemWieslab AB · 1998

All 5 as Wieslab AB →