510(k) K150396

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 by Apex BioTechnology Corp. — Product Code NBW

K150396 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "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". The FDA issued a decision of Substantially Equivalent on October 14, 2015. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Apex BioTechnology Corp. has at least 10 other 510(k) clearances on record.