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510(k) Data Aggregation
K Number
K062892Device Name
EUKARE
Manufacturer
Date Cleared
2007-01-22
(118 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EUMED BIOTECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EUKARE® glucose test strip is intended to measure the glucose in whole blood with the EUKARE® glucose meter. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.
CAUTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.
The EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
CAUTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.
The EUKARE Blood Glucose Test Strips are intended to measure the glucose levels in whole blood with the EUKARE / EUSURE® Blood Glucose Monitoring System. It is suitable for persons with diabetes to monitor their blood glucose levels at home by The system can also be used at clinical sites by health care professionals themselves. to test the blood glucose levels of patients.
CAUTION: The EUKARE Blood Glucose Test Strips for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.
The EUKARE Blood Glucose Control Solution level I, level II, and level III are used as quality control material to verify the accuracy of the EUKARE® / EUSURE® Blood Glucose Monitoring System. If you are not sure about the strip quality or the previous storage condition, you are recommended to perform a quality control check. The control test results should always fall within the designed range listed on the box in use.
CAUTION: The EUKARE Blood Glucose Control Solution for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, EUKARE Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 15 seconds.
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K Number
K040678Device Name
EUSURE BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2004-07-14
(121 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EUMED BIOTECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EUSURE Blood Glucose Monitoring System is designed to measure the blood glucose levels in capillary whole blood. The system is suitable for diabetic patients to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients. The test range is from 30 mg/dL to 600 mg/dL ( 1.67 -3.33 mmol/L).
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, ENSURE system only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 15 seconds.
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Ask a specific question about this device
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