| Device Type ID | 4915 |
| Device Name | D/km-1, Antigen, Antiserum, Control |
| Regulation Description | Human Allotypic Marker Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5065 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DHF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |