510(k) Report

Devices descending from K012119

4 later devices reach Validate Chem 3 Calibration Verification Test Set, Model 10003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc.20023—
+2K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+2K090405Lipidpro SystemInfopia Co, Ltd.20091—
+3K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—