Name: Predicase
Price: 199 USD

K-number	K150396
Device name	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
Applicant	Apex BioTechnology Corp.
Product code	NBW
Device class	Class II
Decision date	Oct 14, 2015
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

Everything you need for a 510(k) submission. Nothing you don't.