FDA applicant
Roche Diagnostics Corp.
FDA records 480 decisions for Roche Diagnostics Corp. (Indianapolis, IN) from 1985 to 2026: 459 510(k) clearances, 4 De Novo grants and 17 original PMA approvals. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 474 predicates, 237 of them its own earlier devices. 170 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Roche Diagnostics”, “Roche Diagnostics GmbH”, “Roche Diagnostics Corporation”, “Roche Diagnostics, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diagnostics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Roche Diagnostics Corp.’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.