Company
Roche Diagnostics Operations Inc.
Company profile in the Orca1 company index
Key facts
| Company name | Roche Diagnostics Operations Inc. |
|---|
At a glance
- 1,000+ 510(k) clearances
- 10–99 De Novo grants
- 10–99 PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 Recall events
- 100–999 Recalled products (Z-numbers)
- None Warning letters
- Oct 2, 2026 Latest 510(k) clearance
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Companies (Orca1 company index)
The Orca1 company index (OMI) resolves the many spellings of a company's name across FDA, NLM and EU datasets into one profile, so every submission, recall, report and inspection rolls up to the right company.
Source: Orca1 company index (OMI), compiled from FDA, NLM and European Commission data