BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OncoMate MSI Dx Analysis System

    K Number: K200129 · Decision Jul 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    552

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    Basic Information

    Device Name
    OncoMate MSI Dx Analysis System
    K Number
    K200129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1866
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promega Corporation
    Date Received
    January 21, 2020
    Decision Date
    July 26, 2021
    Product Code
    PZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PZJ Lynch Syndrome Test System

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