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510(k) Data Aggregation

    K Number
    K091460
    Device Name
    ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
    Date Cleared
    2009-08-06

    (80 days)

    Product Code
    Regulation Number
    862.1660
    Why 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.
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    K Number
    K090943
    Device Name
    ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
    Date Cleared
    2009-05-27

    (54 days)

    Product Code
    Regulation Number
    862.1660
    Why 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.
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    K Number
    K090854
    Device Name
    ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
    Date Cleared
    2009-04-16

    (17 days)

    Product Code
    Regulation Number
    862.1660
    Why 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.
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    K Number
    K083549
    Device Name
    ABT GLUCOSE CONTROL SOLUTION
    Date Cleared
    2008-12-22

    (21 days)

    Product Code
    Regulation Number
    862.1660
    Why 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.
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