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

    GILUCOCHEK REFLECTANCE METER

    K Number: K810665 · Decision Apr 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    257
    Applicant Total
    42
    Review Days
    37

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    Basic Information

    Device Name
    GILUCOCHEK REFLECTANCE METER
    K Number
    K810665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lifescan, Inc.
    Date Received
    March 11, 1981
    Decision Date
    April 17, 1981
    Product Code
    JJQ
    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
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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