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

    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)

    K Number: K861367 · Decision May 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    238
    Review Days
    48

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    Basic Information

    Device Name
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
    K Number
    K861367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    April 11, 1986
    Decision Date
    May 29, 1986
    Product Code
    KLS
    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
    KLS Enzyme Immunoassay, Theophylline

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