510(k) K181131

Accu-Chek Guide Me Blood Glucose Monitoring System by Roche Diabetes Care — Product Code NBW

K181131 is an FDA 510(k) premarket notification submitted by Roche Diabetes Care for the device "Accu-Chek Guide Me Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on December 13, 2018. 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 has at least 10 other 510(k) clearances on record.