K-number	K153538
Device name	Dextramer CMV Kit
Applicant	Immudex Aps
Product code	GKZ
Device class	Class II
Decision date	Mar 2, 2017
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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Dextramer CMV Kit

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