BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Anti-Tumor Cell Susceptibility

    PMA: P940036 · Decision Aug 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Test, Anti-Tumor Cell Susceptibility
    Trade Name
    BARTELS CHEMORESPONSE ASSAY
    PMA Number
    P940036
    Device Class
    FDA Class 3
    Product Code
    MHR
    Generic Name
    Test, anti-tumor cell susceptibility
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 1, 1996
    Date Received
    November 23, 1994
    Expedited Review
    Y
    Docket Number
    96M-0471

    Advisory Committee Statement

    APPROVAL FOR THE BARTELS CHEMORESPONSE ASSAY

    Classifications

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

    Product Code Device Name
    MHR Test, Anti-Tumor Cell Susceptibility