Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
144
results for "Ortho-Clinical Diagnostics"
Cleared
Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
Chemistry
90d
Cleared
Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
Ortho-Clinical Diagnostics
Microbiology
90d
Cleared
May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
183d
Cleared
Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
498d
Cleared
Aug 23, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho-Clinical Diagnostics
Immunology
90d
Cleared
Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho-Clinical Diagnostics
Immunology
75d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS...
Ortho-Clinical Diagnostics, Inc.
Microbiology
591d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS...
Ortho-Clinical Diagnostics, Inc.
Microbiology
592d
Cleared
Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho-Clinical Diagnostics
Immunology
216d
Cleared
Jun 15, 2022
VITROS AFP
Ortho-Clinical Diagnostics
Immunology
210d
Cleared
Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
158d
Cleared
Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
504d
Cleared
Aug 13, 2021
VITROS Chemistry Products PHBR Slides
Ortho-Clinical Diagnostics, Inc.
Toxicology
143d
Cleared
Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
Ortho-Clinical Diagnostics
Microbiology
26d
Cleared
Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
23d
Cleared
Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
28d
Cleared
Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
30d
Cleared
Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
27d
Cleared
Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
29d
Cleared
Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides,...
Ortho-Clinical Diagnostics, Inc.
Chemistry
90d
Cleared
Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,...
Ortho-Clinical Diagnostics, Inc.
Chemistry
90d
Cleared
Sep 18, 2017
VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics
Chemistry
285d
Cleared
Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
Ortho-Clinical Diagnostics
Chemistry
486d
Cleared
May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
Ortho-Clinical Diagnostics
Chemistry
25d