Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus

About This 510(k) Submission

K173638 is an FDA 510(k) clearance for the Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bionime Corporation (Taichung City, TW). The FDA issued a Cleared decision on August 17, 2018, 266 days after receiving the submission on November 24, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.