510(k) K173139

Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus by Bionime Corporation — Product Code NBW

K173139 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus". The FDA issued a decision of Substantially Equivalent on June 19, 2018. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bionime Corporation has at least 10 other 510(k) clearances on record.