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510(k) Data Aggregation
K Number
K053079Device Name
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2006-03-28
(146 days)
Product Code
CGA, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Assure Pro 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Meter:
The Assure Pro Blood Glucose Meter 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Test Strips:
Assure Pro Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Pro 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.
Assure® Pro Control Solution:
For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Description
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure Pro Blood Glucose Test Strips.
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K Number
K051514Device Name
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2005-10-04
(118 days)
Product Code
NBW, CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Assure Pro 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 in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Device Description
The Assure® Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by persons with diabetes to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure® Pro Test Strips.
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K Number
K041881Device Name
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2005-03-25
(256 days)
Product Code
CGA, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. 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.
Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ 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.
For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.
Device Description
The Advance Micro-draw™ Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Advance Micro-draw™ Blood Glucose Test Strips.
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K Number
K033851Device Name
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2004-03-02
(82 days)
Product Code
JIL
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose in urine. These measurements are used in the screening and diagnosis of glucose metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the qualitative measurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.
Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.
The glucose and ketone strips are intended for both professional and over-the-counter use.
Device Description
DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Three configurations are designed for both professional and home use: detecting one or both of the following analytes: glucose, ketone. The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.
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K Number
K031388Device Name
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2003-05-22
(20 days)
Product Code
CGA, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hypoquard Advance 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 persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Device Description
The Hypoquard Advance Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Hypoguard Advance Blood Glucose Test Strips.
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K Number
K024347Device Name
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2003-03-28
(88 days)
Product Code
CGA, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Express 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 persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.
Device Description
The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
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K Number
K022545Device Name
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2002-10-11
(71 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
Device Description
The GlucoBalance Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. The subject device consists of a data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. It should be noted that the software does not recommend any medical treatment or medication dosage level.
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K Number
K020232Device Name
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2002-02-12
(29 days)
Product Code
CGA, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hypoguard ADVANCE™ 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 persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips 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 persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter 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 persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoguard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Description
Not Found
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K Number
K010973Device Name
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
Manufacturer
HYPOGUARD USA, INC.
Date Cleared
2001-09-11
(162 days)
Product Code
JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, KQO, KSL, LJX
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
HYPOGUARD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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