510(k) Report

Devices descending from K070452

11 later devices reach Variant II Hemoglobin A1C Program with Models 270-2101NU through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.20154—
+1K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—
+1K102510Dimensions HB1C Kit, Model DF105ASiemens Healthcare Diagnostics201101
+1K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc.20092—
+1K090737Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection…Bio-Rad Laboratories, Inc.20090—
+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—
+2K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis20121—
+3K130990Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—