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

    IMMULITE 2500 OM-MA, MODEL L5KOP

    K Number: K072794 · Decision Nov 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    25
    Applicant Total
    11
    Review Days
    35

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    Basic Information

    Device Name
    IMMULITE 2500 OM-MA, MODEL L5KOP
    K Number
    K072794
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions Diagnostics
    Date Received
    October 1, 2007
    Decision Date
    November 5, 2007
    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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