510(k) K060617

PTS PANELS HDL CHOLESTEROL TEST STRIPS by Polymer Technology Systems, Inc. — Product Code NAQ

K060617 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "PTS PANELS HDL CHOLESTEROL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on April 5, 2006. The device falls under product code NAQ (Lipoprotein, High Density, Hdl, Over The Counter), a Class I device regulated under 21 CFR 862.1175. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.