Sysmex Corporation of America
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K021241 | SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I | June 25, 2002 |
| K020496 | HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, | April 12, 2002 |
| K001683 | SYSMEX R-500 | August 21, 2000 |