510(k) K160944

ACCU-CHEK Guide Blood Glucose Monitoring System by Roche Diabetes Care, Inc. — Product Code NBW

K160944 is an FDA 510(k) premarket notification submitted by Roche Diabetes Care, Inc. for the device "ACCU-CHEK Guide Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on August 31, 2016. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Roche Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.