Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics, Inc. Chemistry ✕
72 devices
Cleared
Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Chemistry
90d
Cleared
Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
Chemistry
23d
Cleared
Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
Chemistry
28d
Cleared
Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
Chemistry
30d
Cleared
Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
Chemistry
27d
Cleared
Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
Chemistry
29d
Cleared
Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,...
Chemistry
90d
Cleared
Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides,...
Chemistry
90d
Cleared
Oct 18, 2016
VITROS® Automation Solutions
Chemistry
239d
Cleared
May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
Chemistry
28d
Cleared
May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
Chemistry
109d
Cleared
May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE...
Chemistry
146d
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