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510(k) Data Aggregation

    K Number
    K993941

    Validate with FDA (Live)

    Device Name
    UBAS
    Manufacturer
    MARUKIN DIAGNOSTICS
    Date Cleared
    2000-03-02

    (104 days)

    Product Code
    KWX
    Regulation Number
    862.1187
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Marukin Diagnostic's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.

    Device Description

    Assay Kit for Urinary Total Bile Acid Sulfate

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for an "Assay kit for Urinary Total Bile Acid Sulfate." This type of document does not typically contain the detailed study information, acceptance criteria, or performance data that you are requesting.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not provide the specifics of the performance studies that led to this determination. Such details would typically be found in the manufacturer's 510(k) submission summary or in peer-reviewed publications.

    Therefore, I cannot extract the requested information from the provided text. The document only states the intended use of the device: "The Marukin Diagnostic's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults."

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