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510(k) Data Aggregation

    K Number
    K003195
    Device Name
    GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
    Manufacturer
    GREER LABORATORIES, INC.
    Date Cleared
    2000-12-13

    (62 days)

    Product Code
    SCL, 200
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREER LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device system is for use in the prick/puncture application of allergen extracts The epicutaneous layer of the skin in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies. Prick/puncture application of multiple allergen extracts in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.
    Device Description
    The device system is comprised of both single-use and reusable components. The device includes: - 1) The Track a sterile, single-use, injection molded, plastic piece with four sites having four tines each, intended to deliver the allergens into the epicutaneous layer of the skin. The Track is injection molded from a thermoplastic polymer. The material has been tested to meet USP Class VI performance criteria for biocompatibility. The Tracks are packaged in a PETG tray sealed with a tyvek lid, eight Tracks per tray. - 2) A reusable Handle designed to "pick-up" and hold one or two Tracks. The Handle is constructed of a plastic body, stainless steel metal screws, and spring, and a machined, extruded metal trigger/latch mechanism designed to engage and hold the Tracks. - 3) A reusable polystyrene plastic Loading Tray designed to hold one Handle with attached Tracks, and eight vials of allergen extracts.
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