510(k) K201880

MultiSure GK Link Blood Glucose and Ketone Monitoring System by Apex BioTechnology Corp. — Product Code NBW

K201880 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "MultiSure GK Link Blood Glucose and Ketone Monitoring System". The FDA issued a decision of Substantially Equivalent on October 15, 2021. 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.