510(k) Report

Devices descending from K060617

5 later devices reach PTS Panels HDL Cholesterol Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc.200711
+1K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc.200724
+1K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+2K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201602
+2K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc.20140—