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510(k) Data Aggregation

    K Number
    K974606
    Device Name
    RANDOX MAGNESIUM
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1998-02-12

    (64 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Randox Laboratories Limited Magnesium Test Kit is an in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium. Abnormal concentrations of magnesium (elevated or low) are associated with a variety of clinical conditions.

    This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

    Device Description

    in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium.

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for the Randox Magnesium Test Kit (K974606) and a page detailing its indications for use. It does not include acceptance criteria, study details, or performance data for the device. Therefore, I cannot fulfill your request for the information outlined.

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