Roche Diagnostics Hematology
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under 2 spellings of its name, each linked to the record. See the Roche group view.
- 510(k) clearances: 1
- Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 7, 2018 | cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a Class II · Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and t | Device recalls |
| Mar 2, 2018 | cobas m 511 integrated hematology analyzerK171655 · GKZ | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- roche.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built