510(k) K063771

GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM by Arkray Factory USA, Inc. — Product Code NBW

K063771 is an FDA 510(k) premarket notification submitted by Arkray Factory USA, Inc. for the device "GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 9, 2007. 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 USA, Inc. has at least 8 other 510(k) clearances on record.