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510(k) Data Aggregation
K Number
K062538Device Name
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2007-04-30
(244 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
DIACARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
The EASY CHECK Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.
The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)
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