510(k) Report

Devices descending from K011389

1 later device reach Hemoglobin F & A2 Control (Beta-Thalassaemia Control) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053031Extendsure Hbfasc ControlCantebury Scientific, Ltd.20050—