510(k) K152365

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System by Agamatrix, Inc. — Product Code NBW

K152365 is an FDA 510(k) premarket notification submitted by Agamatrix, Inc. for the device "AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Apr 21, 2016. 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, Inc. has at least 10 other 510(k) clearances on record.