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

    Elecsys CA-125 II assay

    K Number: K143534 · Decision Aug 6, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    237

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    Basic Information

    Device Name
    Elecsys CA-125 II assay
    K Number
    K143534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Professional Diagnostics
    Date Received
    December 12, 2014
    Decision Date
    August 6, 2015
    Product Code
    LTK
    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
    LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

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