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510(k) Data Aggregation

    K Number
    K153670
    Device Name
    Genteel Lancing Device
    Manufacturer
    Genteel, LLC
    Date Cleared
    2016-05-12

    (143 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genteel, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. The Genteel lancing device is for Single Patient Use Only.
    Device Description
    The Genteel® Lancing Device (Genteel) is a dual-spring mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The Genteel lancing device is used with commercially available, sterile, standard square shaft blood lancets.
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