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510(k) Data Aggregation

    K Number
    K983432
    Device Name
    SUPREME II CONTROL SOLUTIONS
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1998-12-17

    (79 days)

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

    SUPREME II CONTROL SOLUTIONS

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

    The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose. The solutions are intended for in-vitro use only.

    Device Description

    Supreme II Control Solutions

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Supreme II Control Solutions." This letter indicates that the device has been cleared for market based on its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter is a regulatory document, not a scientific study report.

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