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

    DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT

    K Number: K140859 · Decision Nov 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    152
    Review Days
    237

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    Basic Information

    Device Name
    DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
    K Number
    K140859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    April 3, 2014
    Decision Date
    November 26, 2014
    Product Code
    CEC
    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
    CEC Radioimmunoassay, Free Thyroxine

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