510(k) K071393

JAZZ BLOOD GLUCOSE MONITORING SYSTEM by Agamatrix — Product Code NBW

K071393 is an FDA 510(k) premarket notification submitted by Agamatrix for the device "JAZZ BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 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.