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

    ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

    K Number: K013272 · Decision Oct 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    96
    Review Days
    24

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    Basic Information

    Device Name
    ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
    K Number
    K013272
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    October 1, 2001
    Decision Date
    October 25, 2001
    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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