FDA applicant
Roche Diagnostics Operations
FDA records 9 decisions for Roche Diagnostics Operations (Indianapolis, IN) from 2012 to 2025: 7 510(k) clearances and 2 original PMA approvals. Most are in product codes MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis…) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 8 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Roche Diagnostics Operations, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diagnostics Operations’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Roche Diagnostics Operations’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.