510(k) Report

Devices descending from K941142

4 later devices reach Kodak Ektachem Clinical Chemistry Slide Phenytoin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081543Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…Ortho-Clinical Diagnostics, Inc.2008339
+2K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc.2018120
+2K083173Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…Ortho-Clinical Diagnostics2008026
+3K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.20190—