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

    Lumipulse G ß-Amyloid Ratio (1-42/1-40)

    K Number: DEN200072 · Decision May 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    45
    Review Days
    530

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    Basic Information

    Device Name
    Lumipulse G ß-Amyloid Ratio (1-42/1-40)
    K Number
    DEN200072
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.5840
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    November 20, 2020
    Decision Date
    May 4, 2022
    Product Code
    QSE
    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
    QSE Alzheimer’S Disease Pathology Assessment Test

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