510(k) Report

FDA applicant

Ab Biodisk North America, Inc.

S-17136 Solna, Sweden, SE3 decisions1994–19981 recall

FDA records 3 decisions for Ab Biodisk North America, Inc. (S-17136 Solna, Sweden, SE) from 1994 to 1998: 3 510(k) clearances. All are in product code JWY (Manual Antimicrobial Susceptibility Test Systems). 1 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, microbiology panel, where it files most

How often FDA has decided Ab Biodisk North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ab Biodisk North America, Inc. since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ab Biodisk North America, Inc. 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?

  • JWYManual Antimicrobial Susceptibility Test Systems3decisions

What has FDA decided for it lately?

  • K983252System U3 for GentamicinAb Biodisk North America, Inc. · 1998
  • K950328Amoxicillin/Clavulanic Acid 2/1Ab Biodisk North America, Inc. · 19951 recall
  • K935519Etest for Ampicillin/Sulbactam 2/1Ab Biodisk North America, Inc. · 1994

All 3 as Ab Biodisk North America, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K950328Etest Clinical Amoxi/Clav 2/1 XL 256 US S30, Catalog 412240Nov 9, 2022Class II