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510(k) Data Aggregation
K Number
K043512Device Name
EASYGLUCO IGM-0002 G2
Manufacturer
Date Cleared
2005-04-08
(109 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EASYGLUCO Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The EASYGLUCO Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.
Device Description
The EASYGLUCO Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
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K Number
K043543Device Name
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2005-04-08
(109 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FREEDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
Device Description
The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
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K Number
K031501Device Name
EASYGLUCO, MODEL IGM0002
Manufacturer
Date Cleared
2003-10-16
(156 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
Device Description
The EASYGLUCO™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
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Ask a specific question about this device
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