Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
Ortho-Clinical Diagnostics, Inc. has 104 FDA 510(k) cleared medical devices. Based in Rochester, US.
Latest FDA clearance: Oct 2025. Active since 1997. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Ortho-Clinical Diagnostics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics, Inc.
106 devices
Cleared
Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Chemistry
90d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS...
Microbiology
592d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS...
Microbiology
591d
Cleared
Aug 13, 2021
VITROS Chemistry Products PHBR Slides
Toxicology
143d
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
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