510(k) Report

Devices descending from K081543

3 later devices reach Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc.2018120
+1K083173Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…Ortho-Clinical Diagnostics2008026
+2K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.20190—