K-number	K203680
Device name	BioFire JI Control Panel M420
Applicant	Maine Molecular Quality Controls, Inc.
Product code	PMN
Device class	Class II
Decision date	Jul 22, 2022
Decision	Substantially Equivalent
Regulation	866.3920

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Source

View the full FDA submission: accessdata.fda.gov

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BioFire JI Control Panel M420

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