Selux Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K244044 | PBC Separator with Selux AST System | March 28, 2025 |
| K223493 | PBC Separator with Selux AST System | February 15, 2024 |
| K211748 | Selux AST System; Model AST Gen 1.0 | April 19, 2023 |
| K211759 | Selux AST System; Model AST Gen 1.0 | January 18, 2023 |