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510(k) Data Aggregation

    K Number
    K063855
    Device Name
    LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
    Manufacturer
    LIBERTY HEALTHCARE GROUP, INC.
    Date Cleared
    2007-02-01

    (35 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBERTY HEALTHCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Liberty Blood Glucose Monitoring System.
    Device Description
    The Liberty Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. They are packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
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    K Number
    K060706
    Device Name
    LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
    Manufacturer
    LIBERTY HEALTHCARE GROUP, INC.
    Date Cleared
    2006-04-28

    (43 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBERTY HEALTHCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
    Device Description
    The Liberty Normal Glucose Control consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.
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    K Number
    K060426
    Device Name
    LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
    Manufacturer
    LIBERTY HEALTHCARE GROUP, INC.
    Date Cleared
    2006-03-09

    (16 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBERTY HEALTHCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.
    Device Description
    The Liberty Glucose Normal Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
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    K Number
    K060481
    Device Name
    LIBERTY GLUCOSE CONTROL SOLUTION
    Manufacturer
    LIBERTY HEALTHCARE GROUP, INC.
    Date Cleared
    2006-03-09

    (14 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBERTY HEALTHCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TheraSense FreeStyle Blood Glucose System.
    Device Description
    The Liberty Glucose Control consists of a viscosityadjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
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    K Number
    K052980
    Device Name
    LIBERTY GLUCOSE CONTROL, MODEL 2120031
    Manufacturer
    LIBERTY HEALTHCARE GROUP, INC.
    Date Cleared
    2005-11-30

    (37 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIBERTY HEALTHCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Abbott Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors.
    Device Description
    The Liberty Glucose Control MID consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of qlucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.
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