510(k) Report

Devices descending from K023558

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+1K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc.201602
+1K090405Lipidpro SystemInfopia Co, Ltd.20091—
+1K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc.20050—
+2K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—