510(k) K120423

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 by Bionime Corporation — Product Code NBW

K120423 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650". The FDA issued a decision of Substantially Equivalent on August 3, 2012. 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.