510(k) K024194

ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS by Lifescan, Inc. — Product Code NBW

K024194 is an FDA 510(k) premarket notification submitted by Lifescan, Inc. for the device "ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 7, 2003. 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.