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

    SYSTEM 103 CHEMISTRY ANALYZER

    K Number: K792361 · Decision Dec 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    16
    Review Days
    36

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    Basic Information

    Device Name
    SYSTEM 103 CHEMISTRY ANALYZER
    K Number
    K792361
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gilford Instrument Laboratories, Inc.
    Date Received
    November 21, 1979
    Decision Date
    December 27, 1979
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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