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

    AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE

    K Number: K895465 · Decision Dec 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    505
    Review Days
    107

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    Basic Information

    Device Name
    AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
    K Number
    K895465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    September 11, 1989
    Decision Date
    December 27, 1989
    Product Code
    JIH
    Advisory Committee
    Clinical Toxicology
    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
    JIH Flame Photometry, Lithium

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