510(k) K120945

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST by Hitachi Chemical Diagnostics, Inc. — Product Code CKA

K120945 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.