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

    NEUROCHEMICAL ANALYZER

    K Number: K864729 · Decision Apr 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    130

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    Basic Information

    Device Name
    NEUROCHEMICAL ANALYZER
    K Number
    K864729
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Esa, Inc.
    Date Received
    December 4, 1986
    Decision Date
    April 13, 1987
    Product Code
    LEQ
    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
    LEQ Detectors, Electrochemical, Liquid Chromatography

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