K-number	K222601
Device name	FilmArray Pneumonia Panel plus
Applicant	Biofire Diagnostics, LLC
Product code	QDS
Device class	Class II
Decision date	Oct 27, 2022
Decision	Substantially Equivalent
Regulation	866.4001

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Source

View the full FDA submission: accessdata.fda.gov

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FilmArray Pneumonia Panel plus

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