K-number	DEN170017
Device name	FilmArray Respiratory Panel 2 plus (RP2plus)
Applicant	Biofire Diagnostics, LLC
Product code	PZF
Device class	Class II
Decision date	Nov 24, 2017
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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FilmArray Respiratory Panel 2 plus (RP2plus)

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