510(k) Report

Devices descending from K031380

1 later device reach Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator… through their predicates, nearest generation first.

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