K-number	K230719
Device name	BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
Applicant	Biofire Diagnostics, LLC
Product code	QOF
Device class	Class II
Decision date	Apr 13, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

Everything you need for a 510(k) submission. Nothing you don't.