| Device Type ID | 2401 |
| Device Name | Device, Blood Mixing And Blood Weighing |
| Regulation Description | Blood Mixing Devices And Blood Weighing Devices. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.9195 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KSQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |