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

    MUTYH-Associated Polyposis (MAP)

    K Number: K182784 · Decision Jan 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    109

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    Basic Information

    Device Name
    MUTYH-Associated Polyposis (MAP)
    K Number
    K182784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6090
    Medical Specialty
    Medical Genetics
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    23AndMe, Inc.
    Date Received
    October 1, 2018
    Decision Date
    January 18, 2019
    Product Code
    QAZ
    Advisory Committee
    Medical Genetics
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QAZ Cancer Predisposition Risk Assessment System

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