OncoMate MSI Dx Analysis System

Lynch Syndrome Test System

Promega Corporation

The following data is part of a premarket notification filed by Promega Corporation with the FDA for Oncomate Msi Dx Analysis System.

Pre-market Notification Details

Device IDK200129
510k NumberK200129
Device Name:OncoMate MSI Dx Analysis System
ClassificationLynch Syndrome Test System
Applicant Promega Corporation 2800 Woods Hollow Rd Madison,  WI  53711
ContactRon Wheeler
CorrespondentPamela Swatkowski
Promega Corporation 2800 Woods Hollow Rd Madison,  WI  53711
Product CodePZJ  
CFR Regulation Number864.1866 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2021-07-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849811031717 K200129 000
00849811056864 K200129 000
00849811056857 K200129 000

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