# Ortho-Clinical Diagnostics, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 152 (1984–2025): 142 510(k) clearances, 2 De Novo grants and 8 original PMA approvals
- Names in FDA's records: Ortho-Clinical Diagnostics, Inc. (111); Ortho-Clinical Diagnostics (24); Ortho Clinical Diagnostics (17)
- Product codes: JJX (13), MMI (6), JJY (5), JFY (5), SEI (4), JIX (4), JIT (4), DHX (3), DCK (3), KHS (3), JIS (3), CGZ (3)
- Predicates its devices cite: 191 (67 its own); citations of its devices by later devices: 77 (67 its own)
- Recalls linked to its devices: 221 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Johnson & Johnson Clinical Diagnostics, Inc.: 19 (https://510kreport.com/company/johnson-johnson-clinical-diagnostics)
- Eastman Kodak Company: 18 (https://510kreport.com/company/eastman-kodak)
- Dade Behring, Inc.: 14 (https://510kreport.com/company/dade-behring)
- Bio-Rad: 12 (https://510kreport.com/company/bio-rad)
- Roche Diagnostics Corp.: 8 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 7 (https://510kreport.com/company/abbott-laboratories)
- Beckman Instruments, Inc.: 5 (https://510kreport.com/company/beckman-instruments)
- Behring Diagnostics, Inc.: 5 (https://510kreport.com/company/behring-diagnostics)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 3 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Qualigen, Inc.: 1 (https://510kreport.com/company/qualigen)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Immunalysis Corporation: 1 (https://510kreport.com/company/immunalysis)

## Its most-cited devices
- K041764: The Vitros 5,1 FS Chemistry System (2004), cited by 3
- K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II (2004), cited by 3
- K042476: Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos (2004), cited by 3
- K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System (2008), cited by 2
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303 (2006), cited by 2
- K984288: Vitros Chemistry Products PHBR Slides (1999), cited by 2

## Recent decisions
- K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (Oct 29, 2025)
- K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack (Aug 28, 2024)
- K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
- K221197: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (Sep 5, 2023)
- K231517: VITROS Immunodiagnostic Products CEA Reagent Pack (Aug 23, 2023)
- K231525: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (Aug 9, 2023)
- DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (May 5, 2023)
- DEN210038: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (May 5, 2023)

Source page: https://510kreport.com/company/ortho-clinical-diagnostics