510(k) Report

Devices descending from K926469

22 later devices reach Variant (TM) Hemoglobin a 1C Program through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984268Variant II Hemoglobin A1C ProgramBio-Rad1998212
+2K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc.2007111
+2K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi200611
+2K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc.200412
+2K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc.200434
+2K031043D-10 Hemoglobin A1CBio-Rad Laboratories, Inc.200326
+2K012410Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc.20010—
+3K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.20154—
+3K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—
+3K102510Dimensions HB1C Kit, Model DF105ASiemens Healthcare Diagnostics201101
+3K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc.20092—
+3K090737Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection…Bio-Rad Laboratories, Inc.20090—
+3K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin…Bio-Rad Laboratories Inc., Clinical Systems Divisi200715
+3K063400Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Bio-Rad Laboratories, Inc.200624
+3K060001D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc.200601
+4K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.20260—
+4K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.20250—
+4K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.20240—
+4K182651HbA1c AdvancedBeckman Coulter Ireland, Inc.20190—
+4K140801Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc.20140—
+4K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis20121—
+5K130990Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—