510(k) K112995

GEM PREMIER 4000 by Instrumentation Laboratory CO — Product Code CEM

K112995 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM PREMIER 4000". The FDA issued a decision of Substantially Equivalent on May 3, 2012. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.