K-number	K163569
Device name	Elecsys CMV IgM
Applicant	Roche Diagnostics
Product code	LFZ
Device class	Class II
Decision date	Mar 17, 2017
Decision	Substantially Equivalent
Regulation	866.3175

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys CMV IgM

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