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

    THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609

    K Number: K012878 · Decision Oct 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
    K Number
    K012878
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Dma, Inc.
    Date Received
    August 28, 2001
    Decision Date
    October 16, 2001
    Product Code
    JIS
    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
    JIS Calibrator, Primary

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