K-number	K181493
Device name	FilmArray Blood Culture Identification (BCID) Panel
Applicant	Biofire Diagnostics, LLC
Product code	PEN
Device class	Class II
Decision date	Jul 5, 2018
Decision	Substantially Equivalent
Regulation	866.3365

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Source

View the full FDA submission: accessdata.fda.gov

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FilmArray Blood Culture Identification (BCID) Panel

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