BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P970018 · Supplement: S030 · Decision Feb 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    BD TOTALYS SLIDEPREP
    PMA Number
    P970018
    Supplement Number
    S030
    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
    February 12, 2016
    Date Received
    November 3, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the BD Totalys™ SlidePrep (and use of the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys™ SlidePrep and BD FocalPoint™ Slide Profiler, respectively.

    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