510(k) K092052

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 by Bionime Corporation — Product Code NBW

K092052 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550". The FDA issued a decision of Substantially Equivalent on June 18, 2010. 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.