K-number	K170604
Device name	FilmArray Respiratory Panel 2 (RP2)
Applicant	Biofire Diagnostics, LLC
Product code	OCC
Device class	Class II
Decision date	May 30, 2017
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 2 (RP2)

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