BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Helix Genetic Health Risk App for late-onset Alzheimer’s disease

    K Number: K192073 · Decision Dec 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    509

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    Basic Information

    Device Name
    Helix Genetic Health Risk App for late-onset Alzheimer’s disease
    K Number
    K192073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5950
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helix Opco, LLC
    Date Received
    August 2, 2019
    Decision Date
    December 23, 2020
    Product Code
    PTA
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PTA Genetic Variant Detection And Health Risk Assessment System

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    Other Clearances by Helix Opco, LLC

    K Number Device Name
    DEN190035 Helix Laboratory Platform