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510(k) Data Aggregation

    K Number
    K973345
    Device Name
    MATRIX PLUS MULTI-CALIBRATOR KIT
    Manufacturer
    VERICHEM LABORATORIES, INC.
    Date Cleared
    1997-10-29

    (54 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

    Device Description

    MATRIX PLUS MULTI-CALIBRATOR KIT

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "MATRIX PLUS™ Multi-Calibrator Kit." This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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