510(k) K122858

ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II by Elitechgroup — Product Code JFJ

K122858 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II". The FDA issued a decision of Substantially Equivalent on October 3, 2012. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Elitechgroup has at least 10 other 510(k) clearances on record.