K-number	K163636
Device name	ePlex Respiratory Pathogen Panel
Applicant	Genmark Diagnostics, Incorporated
Product code	OCC
Device class	Class II
Decision date	Jun 9, 2017
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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ePlex Respiratory Pathogen Panel

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