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

    ACCESS OV MONITOR ASSAY

    K Number: K031297 · Decision May 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    25
    Applicant Total
    270
    Review Days
    8

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    Basic Information

    Device Name
    ACCESS OV MONITOR ASSAY
    K Number
    K031297
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    April 24, 2003
    Decision Date
    May 2, 2003
    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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