510(k) K140100

TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM by Nipro Diagnostics, Inc. — Product Code NBW

K140100 is an FDA 510(k) premarket notification submitted by Nipro Diagnostics, Inc. for the device "TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Nipro Diagnostics, Inc. has at least 3 other 510(k) clearances on record.