510(k) Report

Devices descending from K013068

5 later devices reach Bioscanner 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc.200724
+1K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+1K041750PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc.200411
+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—