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

    STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.

    K Number: K894993 · Decision Oct 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    505
    Review Days
    66

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    Basic Information

    Device Name
    STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
    K Number
    K894993
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    August 8, 1989
    Decision Date
    October 13, 1989
    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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