BEUDAMED
    Product Code: MKQ FDA class 3

    Processor, Cervical Cytology Slide, Automated

    Unknown

    The Automated Cervical Cytology Slide Processor is a system designed to collect, prepare, and process cervical cytology specimens, such as those obtained during routine Pap smear screening, in an automated manner to create standardized, high-quality slides for subsequent microscopic or digital analysis to detect cervical abnormalities or precancerous changes. As a Class 3 device, it requires Premarket Approval (PMA) given the diagnostic significance of cervical cancer screening. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MKQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    PA
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.