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

    LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047

    K Number: K063855 · Decision Feb 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    5
    Review Days
    35

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    Basic Information

    Device Name
    LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
    K Number
    K063855
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liberty Healthcare Group, Inc.
    Date Received
    December 28, 2006
    Decision Date
    February 1, 2007
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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    Other Clearances by Liberty Healthcare Group, Inc.

    K Number Device Name
    K060706 LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
    K060481 LIBERTY GLUCOSE CONTROL SOLUTION
    K060426 LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
    K052980 LIBERTY GLUCOSE CONTROL, MODEL 2120031