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

    GEN PROFILER SYSTEM

    K Number: K851619 · Decision May 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    26

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    Basic Information

    Device Name
    GEN PROFILER SYSTEM
    K Number
    K851619
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electro-Cucleonics, Inc.
    Date Received
    April 18, 1985
    Decision Date
    May 14, 1985
    Product Code
    JJG
    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
    JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

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