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

    ANALYZER, IMPACT 200

    K Number: K790072 · Decision Feb 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    16
    Review Days
    42

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    Basic Information

    Device Name
    ANALYZER, IMPACT 200
    K Number
    K790072
    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
    January 11, 1979
    Decision Date
    February 22, 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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