Search Results
Found 4 results
510(k) Data Aggregation
K Number
K091460Device Name
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
Manufacturer
Date Cleared
2009-08-06
(80 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 TRUEresult ™ and TRUE2go™ Meters and TRUEtest™ Test Strips.
Device Description
The AbT Glucose Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities 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.
Ask a Question
Ask a specific question about this device
K Number
K090943Device Name
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
Manufacturer
Date Cleared
2009-05-27
(54 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Agamatrix WaveSense Presto Blood Glucose Monitor.
Device Description
The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. It is packaged in a plastic dropper tipped bottle for easy application of the control solution 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.
Ask a Question
Ask a specific question about this device
K Number
K090854Device Name
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
Manufacturer
Date Cleared
2009-04-16
(17 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Contour TS Blood Glucose Monitor.
Device Description
The AbT Glucose 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.
Ask a Question
Ask a specific question about this device
K Number
K083549Device Name
ABT GLUCOSE CONTROL SOLUTION
Manufacturer
Date Cleared
2008-12-22
(21 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 FreeStyle and FreeStyle Lite Blood Glucose Monitors.
Device Description
The AbT Glucose 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1