510(k) K011479

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM by Inverness Medical Innovations, Inc. — Product Code CGA

K011479 is an FDA 510(k) premarket notification submitted by Inverness Medical Innovations, Inc. for the device "ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 30, 2001. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Inverness Medical Innovations, Inc. has at least 5 other 510(k) clearances on record.