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

    CYFRA 21-1 EIA MODEL 211-10

    K Number: K100831 · Decision May 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    45
    Review Days
    428

    Basic Information

    Device Name
    CYFRA 21-1 EIA MODEL 211-10
    K Number
    K100831
    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 24, 2010
    Decision Date
    May 26, 2011
    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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