Definition: Cber
| Device Type ID | 2424 |
| Device Name | Device, Mixing And Weighing, Semi-automated |
| 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) |
| CFR Regulation Number | 864.9195 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MYJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2424 |
| Device | Device, Mixing And Weighing, Semi-automated |
| Product Code | MYJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Mixing Devices And Blood Weighing Devices. |
| CFR Regulation Number | 864.9195 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MACOPRODUCTIONS S.A.S. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |