| Device Type ID | 3034 |
| Device Name | Anti-sm Antibody, Antigen And Control |
| Regulation Description | Antinuclear Antibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LKP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |