Roche Diagnostics Santa Clara
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009731198 | 3009731198 | Roche Diagnostics Santa Clara | 1 | N | 2026-01-01 | 2881 Scott Blvd. Santa Clara CA US 95050 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 218569 | 1710901118 | K243863 | Opulus™ Lymphoma Precision | QIH | 2025-05-30 |
| 218569 | 1176974879 | ||||
| 218569 | 1393814812 | ||||
| 218569 | 1557491714 | ||||
| 218569 | 1683019601 | ||||
| 218569 | 1915203318 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QIH | 1 | 2025-05-30 |