510(k) K142035

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM by Arkray Factory, Inc. — Product Code NBW

K142035 is an FDA 510(k) premarket notification submitted by Arkray Factory, Inc. for the device "GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Arkray Factory, Inc. has at least 5 other 510(k) clearances on record.