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510(k) Data Aggregation

    K Number
    K973931
    Device Name
    UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1997-11-24

    (40 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    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 urea in serum. For IN VITRO diagnostic use. The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Serum urea plays an important role in the discrimination between prerenal and postrenal azotemia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance of the Urea-SL Assay device. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not contain the specific technical or clinical study data requested.

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