510(k) K223090

GEM Premier ChemSTAT by Instrumentation Laboratory CO — Product Code CGA

K223090 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 January 27, 2023. 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.