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Ortho-Clinical Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 104 products

Total Devices104
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252393 VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI2025-10-29 View
510(k) K210858 VITROS Chemistry Products PHBR SlidesDLZ2021-08-13 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
510(k) K130332 VITROS CHEMISTRY PRODUCTS TRIG SLIDESCDT2013-05-31 View
510(k) K123930 VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIILPS2013-05-15 View
510(k) K121608 VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSMRG2013-02-15 View
510(k) K120765 VITROS CHEMISTRY PRODUCTS ECO2 SLIDESKHS2012-10-24 View
510(k) K120609 VITROS CHEMISTRY PRODUCTS DHDL SLIDESLBS2012-09-07 View
510(k) K093611 VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;KHS2010-04-15 View
510(k) K091861 VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927JGS2009-09-03 View
510(k) K072732 ORTHO T. CRUZI ELISA TEST SYSTEMMIU2009-04-15 View
510(k) K083680 VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258CEM2009-02-27 View
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