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

    CEDIA THEOPHYLLINE ASSAY

    K Number: K884358 · Decision Feb 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    107
    Review Days
    113

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    Basic Information

    Device Name
    CEDIA THEOPHYLLINE ASSAY
    K Number
    K884358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Microgenics Corp.
    Date Received
    October 17, 1988
    Decision Date
    February 7, 1989
    Product Code
    KLS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    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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