510(k) K072854

DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM by Tyson Bioresearch, Inc. — Product Code NBW

K072854 is an FDA 510(k) premarket notification submitted by Tyson Bioresearch, Inc. for the device "DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 30, 2008. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Tyson Bioresearch, Inc. has 12 other 510(k) clearances on record.