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

    CARDIOMPO TEST

    K Number: K050029 · Decision May 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    CARDIOMPO TEST
    K Number
    K050029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prognostix, Inc.
    Date Received
    January 6, 2005
    Decision Date
    May 10, 2005
    Product Code
    NTV
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTV Myeloperoxidase, Immunoassay, System, Test

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