| Device Type ID | 2397 |
| Device Name | System, Test, Combs, Automated |
| Regulation Description | Automated Coombs Test Systems. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2397 |
| Device | System, Test, Combs, Automated |
| Product Code | KSM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Coombs Test Systems. |
| CFR Regulation Number | 864.9300 [🔎] |