BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GLUCOSE HEXOKINASE COIL REAGENT SYSTEM

    K Number: K791760 · Decision Sep 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    89
    Review Days
    22

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    Basic Information

    Device Name
    GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
    K Number
    K791760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fisher Scientific Co., LLC
    Date Received
    September 5, 1979
    Decision Date
    September 27, 1979
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

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