| Device Type ID | 2405 |
| Device Name | System, Processing For Frozen Blood |
| Regulation Description | Processing System For Frozen Blood. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9145 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2405 |
| Device | System, Processing For Frozen Blood |
| Product Code | KSW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Processing System For Frozen Blood. |
| CFR Regulation Number | 864.9145 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS KABI AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 2 |
Noise, Audible | 1 |
| Total Device Problems | 3 |