510(k) K071593

PTS PANELS CHOL+HDL PANEL TEST STRIPS by Polymer Technology Systems, Inc. — Product Code CHH

K071593 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "PTS PANELS CHOL+HDL PANEL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on October 15, 2007. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.