510(k) K864159

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD by Chem-Elec, Inc. — Product Code CHH

K864159 is an FDA 510(k) premarket notification submitted by Chem-Elec, Inc. for the device "SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD". The FDA issued a decision of Substantially Equivalent on June 10, 1988. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Chem-Elec, Inc. has at least 8 other 510(k) clearances on record.