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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lynch Syndrome Test System
510(k) Number K200129
Device Name OncoMate MSI Dx Analysis System
Applicant
Promega Corporation
2800 Woods Hollow Rd.
Madison,  WI  53711
Applicant Contact Ron Wheeler
Correspondent
Promega Corporation
2800 Woods Hollow Rd.
Madison,  WI  53711
Correspondent Contact Pamela Swatkowski
Regulation Number864.1866
Classification Product Code
PZJ  
Date Received01/21/2020
Decision Date 07/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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