510(k) K240637

RIGHTEST Blood Glucose Monitoring System Max Tel by Bionime Corporation — Product Code NBW

K240637 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "RIGHTEST Blood Glucose Monitoring System Max Tel". The FDA issued a decision of Substantially Equivalent on November 4, 2024. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bionime Corporation has at least 10 other 510(k) clearances on record.