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

    MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)

    K Number: K014034 · Decision Dec 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    270
    Review Days
    11

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    Basic Information

    Device Name
    MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
    K Number
    K014034
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    December 7, 2001
    Decision Date
    December 18, 2001
    Product Code
    JFL
    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
    JFL Ph Rate Measurement, Carbon-Dioxide

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