510(k) Report

FDA applicant

Immudex Aps

Copenhagen/Kobenhavn, DK1 decision2017–20170 recalls

FDA records 1 decision for Immudex Aps (Copenhagen/Kobenhavn, DK) in 2017: 1 510(k) clearance. All are in product code GKZ (Counter, Differential Cell). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, hematology panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Immudex Aps by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GKZCounter, Differential Cell1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K153538Dextramer CMV KitImmudex Aps · 2017

The one decision as Immudex Aps →