510(k) Report

Devices descending from K000586

8 later devices reach Bioscanner Triglycerides Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071—
+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
+2K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc.20140—
+2K090405Lipidpro SystemInfopia Co, Ltd.20091—
+2K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc.20050—
+3K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—