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

    COULOCHEM II

    K Number: K903231 · Decision Sep 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    66

    Basic Information

    Device Name
    COULOCHEM II
    K Number
    K903231
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ESA, INC.
    Date Received
    July 23, 1990
    Decision Date
    September 27, 1990
    Product Code
    LEQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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