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510(k) Data Aggregation

    K Number
    K972969
    Device Name
    QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-09-22

    (42 days)

    Product Code
    GIO, JKA
    Regulation Number
    864.6150
    Why did this record match?
    Product Code :

    GIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.
    Device Description
    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.
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