510(k) Report

Devices descending from K142448

6 later devices reach VARIANT II TURBO HbA1c Kit - 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc.20160—
+1K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.20154—
+2K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.20260—
+2K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.20250—
+2K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.20240—
+2K182651HbA1c AdvancedBeckman Coulter Ireland, Inc.20190—