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

    THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050

    K Number: K022108 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    4
    Review Days
    27

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    Basic Information

    Device Name
    THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
    K Number
    K022108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Dma, Inc.
    Date Received
    June 28, 2002
    Decision Date
    July 25, 2002
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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