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510(k) Data Aggregation
K Number
K032029Device Name
BTG SMARTEST GLUCOSE TEST SYSTEM
Manufacturer
Date Cleared
2003-12-18
(170 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
BT MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a 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
A chemical reaction between glucose in whole blood and the chemicals on the test strip produce a current. The meter measures the current and the meter calculates glucose concentrations from the current produced in the reaction.
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