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

    ADVIA Centaur Cytokeratin Fragment 21-1

    K Number: K250925 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    45
    Review Days
    264

    Basic Information

    Device Name
    ADVIA Centaur Cytokeratin Fragment 21-1
    K Number
    K250925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    March 27, 2025
    Decision Date
    December 16, 2025
    Product Code
    OVK
    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
    OVK Cytokeratin Fragments 21-1 Eia Kit

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