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510(k) Data Aggregation

    K Number
    K032029
    Device Name
    BTG SMARTEST GLUCOSE TEST SYSTEM
    Manufacturer
    Date Cleared
    2003-12-18

    (170 days)

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

    BT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
    Device Description
    A chemical reaction between glucose in whole blood and the chemicals on the test strip produce a current. The meter measures the current and the meter calculates glucose concentrations from the current produced in the reaction.
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