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Found 13 results

510(k) Data Aggregation

    K Number
    K090495
    Device Name
    TRUEBALANCE BLOOD GLUCOSE SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2009-03-27

    (30 days)

    Product Code
    NBW, CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions. The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.
    Device Description
    TRUEbalance Blood Glucose System
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    K Number
    K080641
    Device Name
    TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2008-08-19

    (166 days)

    Product Code
    NBW, LFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
    Device Description
    TRUEresult Blood Glucose Monitoring System
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    K Number
    K080710
    Device Name
    TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2008-08-13

    (153 days)

    Product Code
    NBW, LFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
    Device Description
    Not Found
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    K Number
    K070593
    Device Name
    TRACKRECORD DATA MANAGEMENT SOFTWARE
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2007-05-07

    (66 days)

    Product Code
    NBW, JQP
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.
    Device Description
    Not Found
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    K Number
    K060793
    Device Name
    ELEMENT BLOOD GLUCOSE TEST SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2006-07-25

    (124 days)

    Product Code
    NBW, CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Element Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Not Found
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    K Number
    K051147
    Device Name
    SIDEKICK BLOOD GLUCOSE TEST SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2005-07-12

    (69 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Sidekick Blood Glucose Test System
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    K Number
    K042080
    Device Name
    TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2004-08-19

    (16 days)

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

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Not Found
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    K Number
    K040670
    Device Name
    MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2004-03-25

    (10 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Not Found
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    K Number
    K032657
    Device Name
    TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2004-03-24

    (209 days)

    Product Code
    NBW, CGA, JJX
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Not Found
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    K Number
    K030703
    Device Name
    TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2003-07-11

    (127 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
    Device Description
    Not Found
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