K-number	K152579
Device name	FilmArray Respiratory Panel EZ (RP EZ)
Applicant	Biofire Diagnostics, LLC
Product code	OCC
Device class	Class II
Decision date	Oct 3, 2016
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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FilmArray Respiratory Panel EZ (RP EZ)

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