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510(k) Data Aggregation

    K Number
    K141829
    Device Name
    GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CERAGEM MEDISYS INC.
    Date Cleared
    2014-09-24

    (79 days)

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

    CERAGEM MEDISYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The GlucoVitaal H A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The Gluco Vitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GlucoVitaal H1A Blood Glucose Test Strips are for use with the Glood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
    Device Description
    The GlucoVitaal H1A Blood Glucose Monitoring System consists of GlucoVitaal H1A Blood Glucose Test Meter, GlucoVitaal H1A Blood Glucose Test Strips, GlucoVitaal H1A Glucose Control Solution 1 and Control Solution 2, a Lancing device. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set.
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    K Number
    K140141
    Device Name
    LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CERAGEM MEDISYS INC.
    Date Cleared
    2014-07-03

    (162 days)

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

    CERAGEM MEDISYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
    Device Description
    The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and Carrying Case. The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
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    K Number
    K131727
    Device Name
    CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CERAGEM MEDISYS INC.
    Date Cleared
    2014-02-28

    (261 days)

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

    CERAGEM MEDISYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly. The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.
    Device Description
    The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.
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    K Number
    K102751
    Device Name
    LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CERAGEM MEDISYS INC.
    Date Cleared
    2013-02-11

    (872 days)

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

    CERAGEM MEDISYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The LabonaCheck Gluppy Blood Glucose Test Strips are for use with the LabonaCheck Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck Gluppy Control Solution is for use with the LabonaCheck Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.
    Device Description
    The system consists of Test Meter, Test Strips, Code key, Lancing Device, lancets, 3V battery and Carrying Case. The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
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