510(k) Report

Devices descending from K903309

2 later devices reach Roche Cobas Ready Amylase Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.20190—
+1K981216AMYAbbott Laboratories19980—