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510(k) Data Aggregation

    K Number
    K062433
    Device Name
    DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
    Manufacturer
    DIAMICS, INC.
    Date Cleared
    2007-03-16

    (207 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.
    Device Description
    This device consists of a reusable handle and a multi-component assembly. The reusable handle provides a means of expanding and manipulating the CerCol™ Cervical Sample Collector so that the surface areas of the endo-cervix, ecto-cervix and transition zones of the cervix are completely contacted by the CerCol™ Cervical Sample Collector tip for the collection, transport, analysis and testing of exfoliated cervical epithelial cells. The CerCol™ Cervical Sample Collector will be available as a single use, non-sterile disposable device and the reusable handle will be available separately, but both components must be used together as part of the CerCol™ Cervical Sample Collector System.
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