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510(k) Data Aggregation

    K Number
    K992016
    Device Name
    AMUKIN D
    Manufacturer
    AMUCHINA INTL., INC.
    Date Cleared
    2000-01-10

    (209 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMUCHINA INTL., INC.

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

    Amukin-D is a chlorine-based, high-level disinfectant for reprocessing hemodialyzers.

    Device Description

    Amukin-D is a chlorine-based, high-level disinfectant for reprocessing hemodialyzers.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called Amukin-D, a disinfectant for hemodialyzers. It confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the other detailed study information, as this data is not present in the provided document. The letter is solely a regulatory approval based on equivalence, not a summary of performance data from a specific study.

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