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

    SRI T3 IMMOENZYMETRIC ASSAY

    K Number: K910737 · Decision May 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    23
    Review Days
    69

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    Basic Information

    Device Name
    SRI T3 IMMOENZYMETRIC ASSAY
    K Number
    K910737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Serono-Baker Diagnostics, Inc.
    Date Received
    February 21, 1991
    Decision Date
    May 1, 1991
    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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