Name: Predicase
Price: 199 USD

K-number	K213362
Device name	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
Applicant	Biofire Defense, LLC
Product code	QVR
Device class	Class II
Decision date	Mar 22, 2023
Decision	Substantially Equivalent
Regulation	866.4000

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Source

View the full FDA submission: accessdata.fda.gov

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BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

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