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510(k) Data Aggregation
K Number
K043340Device Name
EZ SMART
Manufacturer
Date Cleared
2005-06-02
(181 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
VIP DIAGNOSTICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.
Device Description
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
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