510(k) Report

Devices descending from K063643

1 later device reach Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—