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

    POMC/PCSK1/LEPR CDx Panel

    K Number: DEN200059 · Decision Jan 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    490

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    Basic Information

    Device Name
    POMC/PCSK1/LEPR CDx Panel
    K Number
    DEN200059
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1164
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Preventiongenetics, LLC
    Date Received
    September 18, 2020
    Decision Date
    January 21, 2022
    Product Code
    QRV
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QRV Setmelanotide Eligibility Gene Variant Detection System