510(k) K073416

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM by Arkray Factory USA, Inc. — Product Code CGA

K073416 is an FDA 510(k) premarket notification submitted by Arkray Factory USA, Inc. for the device "ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2008. 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.