BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    TURBOX THEOPHYLLINE ASSAY

    K Number: K882570 · Decision Nov 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    73
    Review Days
    141

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    Basic Information

    Device Name
    TURBOX THEOPHYLLINE ASSAY
    K Number
    K882570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Unipath , Ltd.
    Date Received
    June 22, 1988
    Decision Date
    November 10, 1988
    Product Code
    LER
    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
    LER Fluorescent Immunoassay, Theophylline

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