510(k) K150052

TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System by Nipro Diagnostics, Inc. — Product Code NBW

K150052 is an FDA 510(k) premarket notification submitted by Nipro Diagnostics, Inc. for the device "TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System". The FDA issued a decision of Substantially Equivalent on March 26, 2015. 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.