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510(k) Data Aggregation

    K Number
    K053312
    Device Name
    EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    BIOPTIK TECHNOLOGY, INC.
    Date Cleared
    2006-03-01

    (93 days)

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

    BIOPTIK TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.
    Device Description
    Not Found
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