Data / Medical devices / United States / Roche Diagnostics Santa Clara
Roche Diagnostics Santa Clara: FDA-registered device maker in Santa Clara, CA, United States, 1 510(k) clearance
Roche Diagnostics Santa Clara is registered with the FDA (registration 3009731198) in Santa Clara, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009731198
- Address
- 2881 Scott Blvd., Santa Clara, CA, United States, 95050
- Owner or operator
- Roche Diagnostics Operations Inc. (9039767)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- April 23, 2001
- Registered through
- 2027
- Brand names listed
- 579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, AVENIO Edge System, AVENIO MILLISECT System, Accu-Chek 360° Diabetes Management System Professional, Accu-Chek Care, Accu-Chek Care (HCP) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Specification developer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | K243863 | Opulus Lymphoma Precision | QIH | Substantially Equivalent | Roche Molecular Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Station, Pipetting And Diluting, For Clinical Use
Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.