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510(k) Data Aggregation

    K Number
    K031921
    Device Name
    LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2003-08-25

    (63 days)

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

    LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems is intended for use as an assayed quality control material for analysis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device called "LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems." This document is not a study report and therefore does not contain the information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, or different types of performance studies (MRMC, standalone).

    The document merely states that the device is "substantially equivalent" to legally marketed predicate devices and is intended for use as an "assayed quality control material for analysis." It grants permission to market the device.

    To answer your prompt, a study report or clinical trial document for this specific device would be required. The provided text is a regulatory clearance letter, not a scientific study publication.

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