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FDA 510(k)

Dextramer CMV Kit

K-Number: K153538 · 2017-03-02

ApplicantImmudex Aps
Decision Date2017-03-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Dextramer CMV Kit is a medical device manufactured by Immudex Aps. It received FDA 510(k) clearance on 2017-03-02 under approval 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. It is manufactured by Immudex Aps. The 510(k) number is K153538.

When was Dextramer CMV Kit approved by the FDA?

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

What company makes Dextramer CMV Kit?

Dextramer CMV Kit is manufactured by Immudex Aps.

What is the FDA product code for Dextramer CMV Kit?

The FDA product code for Dextramer CMV Kit is GKZ.

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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.

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