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510(k) Data Aggregation
K Number
K201258Device Name
EASYMAX Tag Self-Monitoring Blood Glucose System
Manufacturer
EPS Bio Technology Corp.
Date Cleared
2021-09-01
(478 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS Bio Technology Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EASYMAX® Tag Self-Monitoring Blood Glucose System is comprised of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The kit is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
Device Description
The modified device of EASYMAX® Tag (EM Tag) self-monitoring blood glucose system is derived from the existing device of EasyMax MU glucose meter and the modified device contain the NFC (Near-field communication) function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
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K Number
K190189Device Name
MDT2 BLE Self-Monitoring Blood Glucose System
Manufacturer
EPS Bio Technology Corp.
Date Cleared
2019-11-01
(273 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS Bio Technology Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
Device Description
The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app.
The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results.
The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
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K Number
K182057Device Name
EasyMax BT Self-Monitoring Blood Glucose System
Manufacturer
EPS Bio Technology Corp.
Date Cleared
2018-08-24
(24 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS Bio Technology Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyMax BT Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EasyMax BT meter and the EasyMax BT test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
Device Description
The modified device of EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The system also includes the control solution which is used to check the performance of the system.
The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
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K Number
K133537Device Name
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2014-04-28
(161 days)
Product Code
LFR, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EGV1.1 Pro Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EGV1.1 Pro meter and the EGV1.1 Pro meter only is used with the EGV1.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EGV . I Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EGV I.I meter and the EGV I.I test strips. The EGV I.I meter only is used with the EGV I.I test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
Device Description
Not Found
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K Number
K133389Device Name
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2014-04-15
(161 days)
Product Code
NBW, LFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EM40 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingerip. Testing is done outside use). It is intended for multiple-patient use in professional healthcare schings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of or screening for diabetes mellitus.
The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EM40 Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EM40 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forcarn. Testing is done outside the body (In Vitro diagnosic use), It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,
The EM40 Glucose Control Solution is for use with EM40 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Device Description
The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,
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K Number
K133647Device Name
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2014-02-27
(92 days)
Product Code
NBW, JJX, LFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMV3.1 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Viro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The system includes the speaking function but is not intended to be operated by visually impaired users.
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EMV3.1 Glucose Control Solution For use with the EMV3.1 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3.1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system includes the speaking function but is not intended to be operated by visually impaired users. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EMV3.1 Glucose Control Solution For use with EMV3.1 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Device Description
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
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K Number
K121207Device Name
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2012-05-18
(28 days)
Product Code
LFR, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
Device Description
The system consists of the EasyMax MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
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K Number
K113243Device Name
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2012-03-28
(147 days)
Product Code
LFR, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EM50 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood form fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is no the be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EM50 Glucose Control Solution For use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Device Description
The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM50 Glucose Control Solution is for use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
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K Number
K112901Device Name
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2011-12-23
(81 days)
Product Code
LFR, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EME Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The EME Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
Device Description
The system consists of the EME meter and the EME test strips. The EME meter only is used with the EME test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The system consists of the EME Pro meter and the EME Pro test strips. The EME Pro meter only is used with the EME Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EME Glucose Control Solution is for use with EME Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EME Glucose Control Solution is for use with the EME Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
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K Number
K111728Device Name
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
EPS BIO TECHNOLOGY CORP.
Date Cleared
2011-09-16
(88 days)
Product Code
CGA, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
EPS BIO TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
Device Description
The system consists of the EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.
The system consists of the EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.
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