K-number	K130914
Device name	FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
Applicant	Biofire Diagnostics, Inc.
Product code	PEN
Device class	Class II
Decision date	Jun 21, 2013
Decision	Substantially Equivalent
Regulation	866.3365

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View the full FDA submission: accessdata.fda.gov

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FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

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