Dextramer CMV Kit— 510(k) K153538

Name: FDA 510(k) clearance K153538
Creator: U.S. Food and Drug Administration
Published: 2017-03-02

Substantially Equivalent

Immudex Aps

FDA 510(k) clearance K153538 for Dextramer CMV Kit, Substantially Equivalent on 2017-03-02. Applicant: Immudex Aps. Device class: 2.

Clearance details

Applicant: Immudex Aps
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2015-12-10
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen/Kobenhavn, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

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K260781 — Yumizen H5502026-09-14
K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
K251249 — Tru Hematology Test2026-01-16
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.