BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TECHNICON FAST-LC SYS. FOR THEOPHYLLINE

    K Number: K791431 · Decision Oct 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    157
    Review Days
    77

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    Basic Information

    Device Name
    TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
    K Number
    K791431
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2270
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    July 26, 1979
    Decision Date
    October 11, 1979
    Product Code
    DPA
    Advisory Committee
    Clinical Chemistry
    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
    DPA Apparatus, General Use, Thin Layer Chromatography

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