K-number	K202196
Device name	BioFire RP2.1/RP2.1plus Control Panel M441
Applicant	Maine Molecular Quality Controls, Inc.
Product code	PMN
Device class	Class II
Decision date	Jun 24, 2021
Decision	Substantially Equivalent
Regulation	866.3920

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Source

View the full FDA submission: accessdata.fda.gov

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BioFire RP2.1/RP2.1plus Control Panel M441

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