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510(k) Data Aggregation

    K Number
    K033921
    Device Name
    AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-03-10

    (83 days)

    Product Code
    JIF
    Regulation Number
    862.1065
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

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

    For the IN VITRO quantitative determination of Ammonia in plasma. Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma

    Device Description

    Ammonia-L3K @ Assay, Cat. No. 233

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Ammonia-L-3K Assay." This type of document is a notification of the agency's decision that the device is substantially equivalent to a predicate device and can be legally marketed. It is not a study report and therefore does not contain information about acceptance criteria or specific study results as requested in the prompt.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than technical performance data.

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