BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TYTEM(R) REAGENT DISPENSER

    K Number: K871687 · Decision May 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    139
    Applicant Total
    17
    Review Days
    21

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    Basic Information

    Device Name
    TYTEM(R) REAGENT DISPENSER
    K Number
    K871687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Laboratory Automation Systems, Inc.
    Date Received
    April 29, 1987
    Decision Date
    May 20, 1987
    Product Code
    JQW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JQW Station, Pipetting And Diluting, For Clinical Use

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