BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIMENSION EXL WITH LM SYSTEM

    K Number: K130276 · Decision Mar 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    152
    Review Days
    45

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    Basic Information

    Device Name
    DIMENSION EXL WITH LM SYSTEM
    K Number
    K130276
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    February 5, 2013
    Decision Date
    March 22, 2013
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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