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510(k) Data Aggregation

    K Number
    K042080
    Device Name
    TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2004-08-19

    (16 days)

    Product Code
    JJX,NBW
    Regulation Number
    862.1660
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a blood glucose monitoring system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Such details would typically be found in the 510(k) summary or the full submission, which are not provided here.

    Therefore, I cannot provide the requested information based on the given text.

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