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510(k) Data Aggregation

    K Number
    K173505
    Device Name
    FORA GTel Blood Glucose Monitoring System
    Manufacturer
    Date Cleared
    2018-08-09

    (269 days)

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

    ForaCare Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FOR A GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared.
    Device Description
    The FORA GTel Blood Glucose Monitoring System consists of FORA GTel blood glucose meter and FORA GTel blood glucose test strip which have been designed, tested, and proven to produce accurate blood glucose test result only when used in combination.
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