510(k) K120448

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL by Apex BioTechnology Corp. — Product Code CGA

K120448 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL". The FDA issued a decision of Substantially Equivalent on April 6, 2012. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Apex BioTechnology Corp. has at least 10 other 510(k) clearances on record.