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    K Number
    K993437
    Device Name
    K-ASSAY C3
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-24

    (43 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY C3

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

    The K-ASSAY Complement C3 Assay is intended to be used for the quantitative determination of Complement C3 in human serum by immunoturbidimetric assay. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry. This document is a letter from the FDA regarding the K-ASSAY C3 device and an "Indications for Use Statement". It does not contain information about acceptance criteria, study details, or device performance metrics. Therefore, I cannot provide the requested table and study information based on the provided text.

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