510(k) K091102

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS by Arkray Factory USA, Inc. — Product Code CGA

K091102 is an FDA 510(k) premarket notification submitted by Arkray Factory USA, Inc. for the device "ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 23, 2009. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Arkray Factory USA, Inc. has at least 8 other 510(k) clearances on record.