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

    STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

    K Number: K933426 · Decision Aug 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    72
    Review Days
    44

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    Basic Information

    Device Name
    STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
    K Number
    K933426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    July 13, 1993
    Decision Date
    August 26, 1993
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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