510(k) Report

FDA applicant

Ab Biomerieux

Solna, SE2 decisions2009–20100 recalls

FDA records 2 decisions for Ab Biomerieux (Solna, SE) from 2009 to 2010: 2 510(k) clearances. Most are in product codes NGZ (Susceptibility Test Plate, Antifungal) and JWY (Manual Antimicrobial Susceptibility Test Systems). 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ab Biomerieux by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ab Biomerieux’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NGZSusceptibility Test Plate, Antifungal1decision
  • JWYManual Antimicrobial Susceptibility Test Systems1decision

What has FDA decided for it lately?

  • K093604Etest Moxifloxacin 0.002-32 UG/MLAb Biomerieux · 2010
  • K082534Etest Voriconazole 0.002-32 UG/MLAb Biomerieux · 2009

All 2 as Ab Biomerieux →