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510(k) Data Aggregation

    K Number
    K022936

    Validate with FDA (Live)

    Device Name
    LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2002-10-02

    (28 days)

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

    LiniCAL™ hsCRP Calibration Verifiers Levels A - E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage TM

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria, device performance tables, study details (sample sizes, data provenance, ground truth, adjudication methods, MRMC studies), or training set information. The document is a 510(k) clearance letter for a medical device (LiniCAL™ hsCRP Calibration Verifiers) and primarily concerns regulatory approval.

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