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510(k) Data Aggregation

    K Number
    K974000
    Device Name
    Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1997-11-04

    (14 days)

    Product Code
    JQB
    Regulation Number
    862.1360
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of λ-GT in serum. For IN VITRO diagnostic use.

    Device Description

    Gamma-Glutamyltransferase-SL Assay

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and details about a study evaluating a device. The document is an FDA letter concerning the 510(k) premarket notification for a "y-Glutamyltransferase-SL Assay." It acknowledges the submission, states the device is substantially equivalent to a predicate device, and outlines regulatory responsibilities. It does not include performance data, study design details, or acceptance criteria for the assay.

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