De Novo Classifications
FDA submissions for De Novo Classifications in the Immunology (IM) review panel, including product codes and regulations.
Section range: §§ 866.5980–866.6120
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QUE | Spinal Muscular Atrophy Newborn Screening Test System | 866.5980 | 2 | 1 |
| QSA | Circulating Tumor Cell (Ctc) Enrichment Device | 866.6110 | 2 | 1 |
| QYO | Hematopoietic Cell Enrichment Kit | 866.6120 | 2 | 1 |
