510(k) Report

Devices descending from K071593

1 later device reach PTS Panels Chol+HDL Panel Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201602