510(k) Report

Devices descending from K063144

3 later devices reach Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.201621
+2K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc.2018120
+3K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.20190—