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

    T4 RIA

    K Number: K833850 · Decision Jan 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    31
    Review Days
    75

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    Basic Information

    Device Name
    T4 RIA
    K Number
    K833850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    November 4, 1983
    Decision Date
    January 18, 1984
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Syncor Intl. Corp.

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    K851033 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
    K844735 PTH-RIA
    K850163 IRIDIUM 192 WIRES
    K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
    K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
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