510(k) Report

Devices descending from K151321

4 later devices reach D-100 HbA1c, D-100 HbA1c Calibrator Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.20260—
+1K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.20250—
+1K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.20240—
+1K182651HbA1c AdvancedBeckman Coulter Ireland, Inc.20190—