BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P040052 · Supplement: S001 · Decision Dec 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    MONOPREP PAP TEST
    PMA Number
    P040052
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MKQ
    Generic Name
    Processor, cervical cytology slide, automated
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 14, 2007
    Date Received
    May 3, 2006
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE POST-APPROVAL STUDY.

    Classifications

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

    Product Code Device Name
    MKQ Processor, Cervical Cytology Slide, Automated