510(k) K183549

GEM Premier ChemSTAT by Instrumentation Laboratory CO — Product Code JGS

K183549 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier ChemSTAT". The FDA issued a decision of Substantially Equivalent on February 16, 2019. 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.