BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P950039 · Decision May 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    THINPREP(R) PROCESSOR, MODEL TP 2000
    PMA Number
    P950039
    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
    May 20, 1996
    Date Received
    November 22, 1995
    Expedited Review
    N
    Docket Number
    97M-0254

    Advisory Committee Statement

    APPROVAL FOR THE THINPREP 2000 SYSTEM

    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