510(k) K131366

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM by Roche Diagnostics Operations, Inc. — Product Code LFR

K131366 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations, Inc. for the device "ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 11, 2013. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics Operations, Inc. has at least 6 other 510(k) clearances on record.