510(k) K080623

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA by Jas Diagnostics, Inc. — Product Code CHH

K080623 is an FDA 510(k) premarket notification submitted by Jas Diagnostics, Inc. for the device "CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA". The FDA issued a decision of Substantially Equivalent on November 17, 2008. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Jas Diagnostics, Inc. has at least 10 other 510(k) clearances on record.