FDA 510(k)

Dextramer CMV Kit

K-Number: K153538 · 2017-03-02

Decision Date2017-03-02

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Dextramer CMV Kit is the device name listed in this FDA 510(k) record. The listed applicant is Immudex Aps. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K153538. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dextramer CMV Kit?

Dextramer CMV Kit is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Immudex Aps. The 510(k) number is K153538.

When did Dextramer CMV Kit receive FDA 510(k) clearance?

Dextramer CMV Kit received FDA 510(k) clearance on 2017-03-02, under 510(k) number K153538.

Who is the listed applicant for Dextramer CMV Kit?

The FDA 510(k) record lists Immudex Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dextramer CMV Kit?

The FDA product code for Dextramer CMV Kit is GKZ.

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.