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510(k) Data Aggregation
K Number
K103230Device Name
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
Manufacturer
Date Cleared
2012-04-24
(540 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or diabetes mellitus, and is not intended for use on neonates.
Device Description
The AP-3000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000 test strips and MAJOR control solution with the AP-3000 Blood Glucose Monitoring System.
The AP-3000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000multi test strips and MAJOR control solution with the AP-3000multi Blood Glucose Monitoring System.
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K Number
K103116Device Name
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2012-03-13
(509 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for testing 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020 Blood Glucose Monitoring Systems is intended for testing 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
The AP-2000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2000 test strips and MAJOR control solution with the AP-2000 Blood Glucose Monitoring System.
The AP-2010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.
The AP-2010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010 test strips and MAJOR control solution with the AP-2010 Blood Glucose Monitoring System.
The AP-2010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.
The AP-2020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2020 test strips and MAJOR control solution with the AP-2020 Blood Glucose Monitoring System.
The AP-2020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2020multi test strips and MAJOR control solution with the AP-2020multi Blood Glucose Monitoring System.
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K Number
K103044Device Name
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
Manufacturer
Date Cleared
2012-02-10
(484 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1010multi Blood Glucose Monitoring System
The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1020 Blood Glucose Monitoring System
The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1020multi Blood Glucose Monitoring System
The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
The AP-1010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010 test strips and MAJOR control solution with the AP-1010 Blood Glucose Monitoring System.
The AP-1010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010multi test strips and MAJOR control solution with the AP-1010multi Blood Glucose Monitoring System.
The AP-1020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020 test strips and MAJOR control solution with the AP-1020 Blood Glucose Monitoring System.
The AP-1020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020multi test strips and MAJOR control solution with the AP-1020multi Blood Glucose Monitoring System.
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K Number
K100437Device Name
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
Manufacturer
Date Cleared
2012-01-12
(694 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AP-1000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. The AP-1000 Blood Glucose Monitoring Systems is intended to be used by a single person and should not be shared. The AP-1000 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh). The AP-1000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing device. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
The AP-1000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000 test strips and MAJOR control solution with the AP-1000 Blood Glucose Monitoring System.
The AP-1000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000multi test strips and MAJOR control solution with the AP-1000multi Blood Glucose Monitoring System.
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K Number
K090389Device Name
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2009-07-14
(147 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Viro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000 Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The AP-1000 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
MAJOR Level I/Level II Control Solutions are for use with the AP-1000 meter and AP-1000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, AP-1000 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 6 seconds.
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K Number
K072274Device Name
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2008-02-29
(198 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BESTGEN BIOTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MAJOR III 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.
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, MAJOR III 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 8 seconds.
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