510(k) Report

Devices descending from K993377

12 later devices reach MTM Bioscanner HDL Test Strips, Over the Counter (Otc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc.20065—
+1K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.200252
+2K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+2K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc.201602
+2K090405Lipidpro SystemInfopia Co, Ltd.20091—
+2K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc.200711
+2K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc.200724
+2K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+2K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc.20050—
+3K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201602
+3K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc.20140—
+3K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—