510(k) K090332

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 by Arkray Factory USA, Inc. — Product Code NBW

K090332 is an FDA 510(k) premarket notification submitted by Arkray Factory USA, Inc. for the device "ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001". The FDA issued a decision of Substantially Equivalent on August 14, 2009. 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.