510(k) Report

Devices descending from K955087

1 later device reach Hemoglobin Alc (HBA1C) & Total Assays for the Technicon RA/Opera Systems… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073309Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentHoriba Abx20080—