510(k) Report

Devices descending from K991127

5 later devices reach Variant II B-Thalassemia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)20230—
+1K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi200611
+1K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc.200412
+2K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—
+2K060001D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc.200601