FDA 510(k) Application Details - K200129

Device Classification Name	More FDA Info for this Device
510(K) Number	K200129
Device Name	OncoMate MSI Dx Analysis System
Applicant	Promega Corporation 2800 Woods Hollow Rd Madison, WI 53711 US Other 510(k) Applications for this Company
Contact	Ron Wheeler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2020
Decision Date	07/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review