510(k) K071507

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

K071507 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on September 10, 2007. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.