510(k) K181273

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System by I-Sens, Inc. — Product Code NBW

K181273 is an FDA 510(k) premarket notification submitted by I-Sens, Inc. for the device "GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on November 1, 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. I-Sens, Inc. has at least 10 other 510(k) clearances on record.