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510(k) Data Aggregation

    K Number
    K062187
    Device Name
    BETACHEK GLUCOSE TEST
    Date Cleared
    2009-03-24

    (966 days)

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

    NATIONAL DIAGNOSTIC PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick. Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician. Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant. This test can not be used to screen or diagnose diabetes. It should not be used for children or by individuals who are diabetic or pregnant. This test is only intended for individual use at home. It is not for use as part of a screening program in a healthcare setting or any other setting.
    Device Description
    Reagent test principle - glucose oxidase
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