510(k) K140068

CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM by Polymer Technology Systems, Inc. — Product Code NBW

K140068 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 22, 2015. 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.