510(k) K153644

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II by Elitechgroup — Product Code CFR

K153644 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II". The FDA issued a decision of Substantially Equivalent on September 7, 2016. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Elitechgroup has at least 10 other 510(k) clearances on record.