510(k) K042443

SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL by Arkray, Inc. — Product Code CHH

K042443 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL". The FDA issued a decision of Substantially Equivalent on November 24, 2004. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Arkray, Inc. has at least 10 other 510(k) clearances on record.