510(k) K053635

MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM by Bionime Corporation — Product Code NBW

K053635 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 2006. 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.