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

    T3 CLASP RIA KIT

    K Number: K771142 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    143
    Applicant Total
    32
    Review Days
    17

    Basic Information

    Device Name
    T3 CLASP RIA KIT
    K Number
    K771142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E. R. SQUIBB & SONS, INC.
    Date Received
    June 27, 1977
    Decision Date
    July 14, 1977
    Product Code
    CDP
    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
    CDP Radioimmunoassay, Total Triiodothyronine

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