510(k) Report

Devices descending from K090413

3 later devices reach A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics201801
+1K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd.20170—
+1K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc.20150—