LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040455
    Device Name
    LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2004-03-05

    (11 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K040193
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CLINIQA LiniCAL™ Uric Acid Calibration Verifiers Levels A – E for Olympus AU Systems™ CLINIQA LiniCAL - Ont Atla Control products which may be used to evaluations are "assayed," liquid," quality" ontrol production with in the useful concentrations.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter, not a study report. It states that the FDA reviewed a 510(k) premarket notification for the "LiniCAL™ Uric Acid Calibration Verifiers Levels A-E for Olympus AU Systems" and determined the device is "substantially equivalent" to legally marketed predicate devices.

    Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study. The letter is an FDA clearance, not a study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1