510(k) K161818

GEM Premier 3000 by Instrumentation Laboratory CO — Product Code CGA

K161818 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier 3000". The FDA issued a decision of Substantially Equivalent on September 14, 2016. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.