510(k) Report

Devices descending from K961099

3 later devices reach Ektachem Clinical Chemistry Slide Sodium (NA+) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.200824
+2K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc.20091—
+3K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20100—