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510(k) Data Aggregation
K Number
K072369Device Name
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
HMD BIOMEDICAL LLC
Date Cleared
2008-03-21
(211 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HMD BIOMEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evolution™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Evolution™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when alucose is not changing rapidly.
Device Description
The Evolution™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Evolution™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood qlucose result.
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