510(k) Report

Devices descending from K861386

4 later devices reach Kodak Ektachem Clinical Chemistry Slides (MG) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040115Piccolo Magnesium Test SystemAbaxis, Inc.20040—
+1K023876Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1Ortho-Clinical Diagnostics, Inc.200221
+2K072440Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…Ortho-Clinical Diagnostics, Inc.200714
+3K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.20190—