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

    PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

    K Number: K854324 · Decision Dec 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    16
    Review Days
    38

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    Basic Information

    Device Name
    PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
    K Number
    K854324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pantex, Div. Bio-Analysis, Inc.
    Date Received
    October 28, 1985
    Decision Date
    December 5, 1985
    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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