510(k) Report

Devices descending from K984303

6 later devices reach Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.200151
+2K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc.200744
+3K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.200731
+4K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.200824
+5K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc.20091—
+6K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20100—