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510(k) Data Aggregation

    K Number
    K971477
    Device Name
    UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    1997-05-27

    (34 days)

    Product Code
    CDQ,CDO
    Regulation Number
    862.1770
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

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

    Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.

    "This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770

    Device Description

    TRACE Urea (Urea Nitrogen) - DST Reagent

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this document.

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