510(k) K160225

GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator by Instrumentation Laboratory CO — Product Code JGS

K160225 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator". The FDA issued a decision of Substantially Equivalent on December 14, 2016. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.