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

    TRIIODOTHYRONINE RIA SYSTEM

    K Number: K792539 · Decision Jan 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    9
    Review Days
    37

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    Basic Information

    Device Name
    TRIIODOTHYRONINE RIA SYSTEM
    K Number
    K792539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radioimmunoassay, Inc.
    Date Received
    December 10, 1979
    Decision Date
    January 16, 1980
    Product Code
    CDP
    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
    CDP Radioimmunoassay, Total Triiodothyronine

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    Other Clearances by Radioimmunoassay, Inc.

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    K780671 125 I-T3 UPTAKE REAGENT
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