Name: Predicase
Price: 199 USD

K-number	K230868
Device name	SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
Applicant	Maine Molecular Quality Controls, Inc.
Product code	PMN
Device class	Class II
Decision date	Apr 13, 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 Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

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