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510(k) Data Aggregation

    K Number
    K990980
    Device Name
    BUN, MODEL BU 104-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (63 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

    The Urea Nitrogen (BUN) reagent is intended for Invitro Diagnostic useein the quantitative determination of urea nitrogen in serum or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "UREA Nitrogen (BUN)". This document does not contain the specific information required to answer your questions about acceptance criteria, study details, ground truth, or expert involvement. The letter simply states that the device is substantially equivalent to a legally marketed predicate device and can, therefore, be marketed.

    This type of FDA letter typically references a 510(k) submission document which would contain the study details. Without that submission, I cannot provide the requested information.

    Therefore, I must state that the requested information is not available in the provided text.

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