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

    IL T UPTAKE ASSAY SYSTEM

    K Number: K903396 · Decision Oct 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    321
    Review Days
    77

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    Basic Information

    Device Name
    IL T UPTAKE ASSAY SYSTEM
    K Number
    K903396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    July 27, 1990
    Decision Date
    October 12, 1990
    Product Code
    KHQ
    Advisory Committee
    Clinical Chemistry
    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
    KHQ Radioassay, Triiodothyronine Uptake

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