510(k) Report

Devices descending from K961226

2 later devices reach Ektachem Clinical Chemistry Calcium (CA) Slide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072440Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…Ortho-Clinical Diagnostics, Inc.200714
+2K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.20190—