510(k) K143548

TRUE METRIX GO Self Monitoring Blood Glucose System by Trividia Health, Inc. — Product Code NBW

K143548 is an FDA 510(k) premarket notification submitted by Trividia Health, Inc. for the device "TRUE METRIX GO Self Monitoring Blood Glucose System". The FDA issued a decision of Substantially Equivalent on April 1, 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. Trividia Health, Inc. has at least 1 other 510(k) clearance on record.