Roche Diagnostics Hematology
FDA Regulatory Profile
Roche Diagnostics Hematology appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2557-2018, Class II) was initiated on May 7, 2018. Its most recent 510(k) clearance was granted on March 2, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2557-2018 | Class II | cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m | May 7, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171655 | cobas m 511 integrated hematology analyzer | March 2, 2018 |