Name: Predicase
Price: 199 USD

K-number	K221253
Device name	SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
Applicant	Maine Molecular Quality Controls, Inc.
Product code	PMN
Device class	Class II
Decision date	Feb 3, 2023
Decision	Substantially Equivalent
Regulation	866.3920

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Source

View the full FDA submission: accessdata.fda.gov

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SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

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