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

    BAKER TDM THEOPHYLLINE ASSAY

    K Number: K873596 · Decision Oct 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    10
    Review Days
    46

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    Basic Information

    Device Name
    BAKER TDM THEOPHYLLINE ASSAY
    K Number
    K873596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Baker Instructions Corp.
    Date Received
    September 4, 1987
    Decision Date
    October 20, 1987
    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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