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

    SODIUM TEST KIT

    K Number: K832552 · Decision Sep 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    92
    Review Days
    50

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    Basic Information

    Device Name
    SODIUM TEST KIT
    K Number
    K832552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    August 1, 1983
    Decision Date
    September 20, 1983
    Product Code
    CEI
    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
    CEI Uranyl Acetate/Zinc Acetate, Sodium

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