510(k) K183555

GEM Premier ChemSTAT by Instrumentation Laboratory CO — Product Code JFY

K183555 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 JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.