K-number	K153223
Device name	ProParaFlu+ Assay
Applicant	Hologic, Inc.
Product code	OOU
Device class	Class II
Decision date	Dec 9, 2015
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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ProParaFlu+ Assay

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