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

    Elecsys Phospho-Tau (181P) Plasma

    K Number: K252163 · Decision Oct 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    183
    Review Days
    90

    Basic Information

    Device Name
    Elecsys Phospho-Tau (181P) Plasma
    K Number
    K252163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5840
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    July 10, 2025
    Decision Date
    October 8, 2025
    Product Code
    SET
    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
    SET Immunoassay Blood Test For Amyloid Pathology Assessment

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