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510(k) Data Aggregation

    K Number
    K143548
    Device Name
    TRUE METRIX GO Self Monitoring Blood Glucose System
    Manufacturer
    Trividia Health, Inc.
    Date Cleared
    2016-04-01

    (473 days)

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

    Trividia Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing. The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
    Device Description
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