510(k) K220421

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System by Apex BioTechnology Corp. — Product Code NBW

K220421 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Apex BioTechnology Corp. has at least 10 other 510(k) clearances on record.