510(k) K113547

GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL by Apex BioTechnology Corp. — Product Code CGA

K113547 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL". The FDA issued a decision of Substantially Equivalent on March 28, 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.