510(k) Report

Devices descending from K031539

2 later devices reach Hemoglobin A1C Reagent Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation20160—
+1K100547Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set…Seppim S.A.S.20110—