510(k) K240640

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System by Sejoy Biomedical Co., Ltd. — Product Code NBW

K240640 is an FDA 510(k) premarket notification submitted by Sejoy Biomedical Co., Ltd. for the device "Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on October 8, 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.