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Ortho-Clinical Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories13
Latest FDA decision2025-10-29
TypeNumberDevice NameCodeDateActions
510(k) K252393 VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI2025-10-29 View
PMA P090028 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2023-01-24 View
PMA P030026 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2023-01-24 View
510(k) K210858 VITROS Chemistry Products PHBR SlidesDLZ2021-08-13 View
PMA P000014 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2020-10-22 View
PMA P010021 Assay, enzyme linked immunosorbent, hepatitis c virusMZO2020-08-07 View
PMA P000044 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2019-06-19 View
510(k) K191316 VITROS XT Chemistry Products ALB-TP SlidesCIX2019-06-07 View
510(k) K190807 VITROS XT Chemistry Products TBIL-ALKP SlidesCIG2019-04-26 View
510(k) K190520 VITROS XT Chemistry Products GLU-Ca SlidesCGA2019-04-03 View
510(k) K190490 VITROS XT Chemistry Products TRIG-CHOL SlidesCHH2019-03-27 View
510(k) K190326 VITROS XT Chemistry Products UREA-CREA SlidesCDN2019-03-14 View
510(k) K182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemJFY2018-10-30 View
510(k) K182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesCGZ2018-10-30 View
510(k) K160495 VITROS® Automation SolutionsKLI2016-10-18 View
510(k) K161140 VITROS Chemistry Products Calibrator Kit 3JIX2016-05-20 View
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