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510(k) Data Aggregation

    K Number
    K023661
    Device Name
    LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2002-12-06

    (36 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K101226
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a quality control material (LiniCAL™ RF-CRP Calibration Verifiers). It does not contain information about the device's acceptance criteria, performance study details, or ground truth establishment. This type of device is a "quality control material," which is used to verify the calibration of an analytical instrument (in this case, for C-reactive protein measurement on Beckman Coulter Synchron CX® Systems). The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

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