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    K Number
    K042551
    Device Name
    MULTI-CHEM CALIBRATOR A
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-11-16

    (57 days)

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

    MULTI-CHEM CALIBRATOR A

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

    The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a medical device. However, the provided document does not contain any information about acceptance criteria, study design, or device performance data.

    The letter is a regulatory document affirming that the device, "Multi-Chem Calibrator A," is substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, regulatory class, and product code, along with the device's intended use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input. The information you are looking for (acceptance criteria, study details, sample sizes, ground truth, etc.) would typically be found in the 510(k) summary, test reports, or clinical study reports, which are not part of this document.

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