510(k) K151552

ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II by Elitechgroup — Product Code JIX

K151552 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II". The FDA issued a decision of Substantially Equivalent on July 8, 2015. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Elitechgroup has at least 10 other 510(k) clearances on record.