BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    PMA: P940035 · Supplement: S009 · Decision Apr 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    System, Test, Tumor Marker, For Detection Of Bladder Cancer
    Trade Name
    NMP22 BLADDERCHEK TEST
    PMA Number
    P940035
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    NAH
    Generic Name
    System, test, tumor marker, for detection of bladder cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 2, 2013
    Date Received
    March 18, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer