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510(k) Data Aggregation

    K Number
    K043460
    Device Name
    OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2005-01-31

    (47 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a calibrator device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.

    The document discusses the substantial equivalence of the "Olympus Lyophilized Chemistry Calibrator" to a legally marketed predicate device. It confirms the device's classification and allows it to proceed to market. The "Indications for Use Statement" clarifies that it's a two-level general-purpose chemistry calibrator for Olympus analyzers using Olympus methodologies.

    In summary, none of the requested information regarding AI/ML device performance or studies is present in this 510(k) document.

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