510(k) K111753

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE by Hitachi Chemical Diagnostics, Inc. — Product Code CHH

K111753 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.