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

    VISTA TRIIODOTHYRONINE ASSAY

    K Number: K923571 · Decision Oct 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    448
    Review Days
    90

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    Basic Information

    Device Name
    VISTA TRIIODOTHYRONINE ASSAY
    K Number
    K923571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syva Co.
    Date Received
    July 17, 1992
    Decision Date
    October 15, 1992
    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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