510(k) Report

Devices descending from K801295

1 later device reach Cobas Reagent for a-Amylase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062180Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPHoriba Abx20060—