510(k) Report

Devices descending from K870012

13 later devices reach Triglyceride (Gpo-Trinder) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991894Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc.200012—
+2K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+2K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.200191
+3K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc.20140—
+3K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.200271
+3K014099Bioscanner PlusPolymer Technology Systems, Inc.20017—
+4K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.201564
+5K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics20220—
+5K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201801
+5K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.20171—
+5K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc.201602
+5K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc.20150—
+6K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—