510(k) K053529

ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM by Lifescan, Inc. — Product Code NBW

K053529 is an FDA 510(k) premarket notification submitted by Lifescan, Inc. for the device "ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 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. Lifescan, Inc. has at least 10 other 510(k) clearances on record.