FDA applicant
Roche Diagnostics Operations (Rdo)
FDA records 14 decisions for Roche Diagnostics Operations (Rdo) (Indianapolis, IN) from 2014 to 2020: 14 510(k) clearances. Most are in product codes PDJ (Hemoglobin A1c Test System) and DKB (Calibrators, Drug Mixture). Its devices cite 14 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diagnostics Operations (Rdo)’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Roche Diagnostics Operations (Rdo)’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 “Roche”
FDA records each applicant name separately; these may or may not be the same firm.