Name: Predicase
Price: 199 USD

K-number	K220870
Device name	BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
Applicant	Biofire Defense, LLC
Product code	QMV
Device class	Class II
Decision date	Oct 20, 2022
Decision	Substantially Equivalent
Regulation	866.3966

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Source

View the full FDA submission: accessdata.fda.gov

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BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

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