BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

    K Number: K250159 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    43
    Review Days
    269

    Basic Information

    Device Name
    Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
    K Number
    K250159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    January 21, 2025
    Decision Date
    October 17, 2025
    Product Code
    SGG
    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
    SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

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