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Found 5 results
510(k) Data Aggregation
K Number
K063855Device 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
862.1660Why 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
K060706Device Name
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
Manufacturer
LIBERTY HEALTHCARE GROUP, INC.
Date Cleared
2006-04-28
(43 days)
Product Code
JJX
Regulation Number
862.1660Why 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
K060426Device 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
862.1660Why 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
K060481Device Name
LIBERTY GLUCOSE CONTROL SOLUTION
Manufacturer
LIBERTY HEALTHCARE GROUP, INC.
Date Cleared
2006-03-09
(14 days)
Product Code
JJX
Regulation Number
862.1660Why 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
K052980Device Name
LIBERTY GLUCOSE CONTROL, MODEL 2120031
Manufacturer
LIBERTY HEALTHCARE GROUP, INC.
Date Cleared
2005-11-30
(37 days)
Product Code
JJX
Regulation Number
862.1660Why 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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