FDA applicant
Ortho-Clinical Diagnostics, Inc.
FDA records 152 decisions for Ortho-Clinical Diagnostics, Inc. (Rochester, NY) from 1984 to 2025: 142 510(k) clearances, 2 De Novo grants and 8 original PMA approvals. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and MMI (Immunoassay Method, Troponin Subunit). Its devices cite 191 predicates, 67 of them its own earlier devices. 221 recalls are linked to its devices.
FDA’s records also spell it “Ortho-Clinical Diagnostics”, “Ortho Clinical Diagnostics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho-Clinical Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
10in 2025
Class I Class II/III not classified
Planning a device like Ortho-Clinical Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Ortho-Clinical”
FDA records each applicant name separately; these may or may not be the same firm.