510(k) Report

Devices descending from K160495

2 later devices reach VITROS® Automation Solutions through their predicates, nearest generation first.

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