K-number	K123620
Device name	FILMARRAY RESPIRATORY PANEL (RP)
Applicant	Biofire Diagnostics, Inc.
Product code	OCC
Device class	Class II
Decision date	Feb 11, 2013
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 (RP)

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