K-number	DEN200031
Device name	BioFire Respiratory Panel 2.1 (RP2.1)
Applicant	Biofire Diagnostics, LLC
Product code	QOF
Device class	Class II
Decision date	Mar 17, 2021
Decision	Not Substantially Equivalent
Regulation	866.3981

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View the full FDA submission: accessdata.fda.gov

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BioFire Respiratory Panel 2.1 (RP2.1)

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