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510(k) Data Aggregation

    K Number
    K051651
    Device Name
    G4, MODEL IGM-0004
    Manufacturer
    U. S. DIAGNOSTICS, INC.
    Date Cleared
    2006-04-14

    (297 days)

    Product Code
    NBW, CGA, JJX
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    U. S. DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm. The G4™ Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm. The G4™ Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.
    Device Description
    The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood, which is used with the G4TM Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
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