FDA applicant
Ortho Diagnostic Systems, Inc.
FDA records 126 decisions for Ortho Diagnostic Systems, Inc. (Carpinteria, CA) from 1981 to 1997: 126 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 8 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho Diagnostic Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ortho Diagnostic Systems, Inc. since 2007.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Ortho Diagnostic Systems, 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”
FDA records each applicant name separately; these may or may not be the same firm.