510(k) K063409

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 by Agamatrix — Product Code NBW

K063409 is an FDA 510(k) premarket notification submitted by Agamatrix for the device "LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067". The FDA issued a decision of Substantially Equivalent on January 12, 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. Agamatrix has at least 10 other 510(k) clearances on record.