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

    NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT

    K Number: K021231 · Decision Jul 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    103

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    Basic Information

    Device Name
    NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
    K Number
    K021231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Matritech, Inc.
    Date Received
    April 18, 2002
    Decision Date
    July 30, 2002
    Product Code
    MMW
    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
    MMW System, Test, Tumor Marker, Monitoring, Bladder

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