FDA applicant
Roche Diagnostics/Boehringer Mannheim GmbH
FDA records 3 decisions for Roche Diagnostics/Boehringer Mannheim GmbH (Indianapolis, IN) from 1998 to 1999: 3 510(k) clearances. Most are in product codes CGN (Acid, Folic, Radioimmunoassay) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diagnostics/Boehringer Mannheim GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Roche Diagnostics/Boehringer Mannheim GmbH since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Roche Diagnostics/Boehringer Mannheim…’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.