510(k) K082417

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 by Arkray Factory USA, Inc. — Product Code CGA

K082417 is an FDA 510(k) premarket notification submitted by Arkray Factory USA, Inc. for the device "GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110". The FDA issued a decision of Substantially Equivalent on October 21, 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.