510(k) Report

Devices descending from K001310

3 later devices reach Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063591Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.200622
+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—