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

    Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

    K Number: K151378 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    45
    Review Days
    186

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    Basic Information

    Device Name
    Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
    K Number
    K151378
    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
    May 22, 2015
    Decision Date
    November 24, 2015
    Product Code
    OIU
    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
    OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)

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