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

    CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

    K Number: K964098 · Decision Oct 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    25
    Applicant Total
    96
    Review Days
    385

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    Basic Information

    Device Name
    CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
    K Number
    K964098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    October 11, 1996
    Decision Date
    October 31, 1997
    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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