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510(k) Data Aggregation

    K Number
    K983707
    Device Name
    JMS DIALYZER PRIMING SET
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-01-08

    (79 days)

    Product Code
    KOC
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is connected with Blood Tubing Set and used to prime Dialyzer and Blood Tubing Set. JMS Dialyzer Priming Set must be discarded after one time use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "JMS Dialyzer Priming Set." The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. It does not include details about pre-market studies, acceptance criteria, or performance metrics. Therefore, I cannot fulfill your request to describe these elements.

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