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

    TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

    K Number: K902243 · Decision Jul 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    157
    Review Days
    48

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    Basic Information

    Device Name
    TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
    K Number
    K902243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    May 18, 1990
    Decision Date
    July 5, 1990
    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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