510(k) Report

Devices descending from K883861

5 later devices reach Document (TM) Protein/Cholesterol Linearity Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012119Validate Chem 3 Calibration Verification Test Set, Model 10003Maine Standards Co.20014—
+2K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc.20023—
+3K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor20170—
+3K090405Lipidpro SystemInfopia Co, Ltd.20091—
+4K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—