Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
106
results for "Ortho-Clinical Diagnostics, Inc."
Cleared
Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
Chemistry
90d
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
Aug 13, 2021
VITROS Chemistry Products PHBR Slides
Ortho-Clinical Diagnostics, Inc.
Toxicology
143d
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
Oct 18, 2016
VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc.
Chemistry
239d
Cleared
May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
Ortho-Clinical Diagnostics, Inc.
Chemistry
28d
Cleared
May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
Ortho-Clinical Diagnostics, Inc.
Chemistry
109d
Cleared
May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE...
Ortho-Clinical Diagnostics, Inc.
Chemistry
146d
Cleared
Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN...
Ortho-Clinical Diagnostics, Inc.
Chemistry
259d
Cleared
Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Ortho-Clinical Diagnostics, Inc.
Chemistry
225d
Cleared
Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Ortho-Clinical Diagnostics, Inc.
Chemistry
191d
Cleared
Apr 15, 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
Ortho-Clinical Diagnostics, Inc.
Chemistry
143d
Cleared
Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR...
Ortho-Clinical Diagnostics, Inc.
Chemistry
76d
Cleared
Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
Ortho-Clinical Diagnostics, Inc.
Microbiology
567d
Cleared
Feb 27, 2009
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT...
Ortho-Clinical Diagnostics, Inc.
Chemistry
77d
Cleared
Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
Ortho-Clinical Diagnostics, Inc.
Chemistry
143d
Cleared
Aug 21, 2008
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
Ortho-Clinical Diagnostics, Inc.
Chemistry
27d