| Device Type ID | 2398 |
| Device Name | Centrifuge, Cell-washing, Automated For Immuno-hematology |
| Regulation Description | Automated Cell-washing Centrifuge For Immuno-hematology. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9285 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |