510(k) Report

Devices descending from K013173

9 later devices reach Bioscanner Plus; Lipid Panel Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.200271
+1K014099Bioscanner PlusPolymer Technology Systems, Inc.20017—
+2K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.201564
+3K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics20220—
+3K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201801
+3K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.20171—
+3K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc.201602
+3K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc.20150—
+4K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—