510(k) K123008

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN by Bionime Corporation — Product Code NBW

K123008 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN". The FDA issued a decision of Substantially Equivalent on January 25, 2013. 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.