510(k) Report

Devices descending from K881773

8 later devices reach Document (TM) Direct Ise Linearity Test Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020450Validate Chem 8 Calibration Verification Test Set; Model 108Maine Standards Co.20020—
+1K012118Validate Chem 2 Calibration Verification Test Set, Model 10002Maine Standards Co.20010—
+1K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co.20015—
+2K050504Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co.20050—
+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—