K-number	K200129
Device name	OncoMate MSI Dx Analysis System
Applicant	Promega Corporation
Product code	PZJ
Device class	Class II
Decision date	Jul 26, 2021
Decision	Substantially Equivalent
Regulation	864.1866

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Source

View the full FDA submission: accessdata.fda.gov

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OncoMate MSI Dx Analysis System

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