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

    ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

    K Number: K110874 · Decision Jan 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    152
    Review Days
    297

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    Basic Information

    Device Name
    ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
    K Number
    K110874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    March 29, 2011
    Decision Date
    January 20, 2012
    Product Code
    JZG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JZG System, Test, Beta-2-Microglobulin Immunological

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