510(k) K124021

ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM by Arkray Factory, Inc. — Product Code CGA

K124021 is an FDA 510(k) premarket notification submitted by Arkray Factory, Inc. for the device "ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 2014. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Arkray Factory, Inc. has at least 5 other 510(k) clearances on record.