510(k) K130685

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY by Hitachi Chemical Diagnostics, Inc. — Product Code JFJ

K130685 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY". The FDA issued a decision of Substantially Equivalent on August 9, 2013. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.