| Device Type ID | 4850 |
| Device Name | Spinner System, Cell Culture |
| Regulation Description | Cell And Tissue Culture Supplies And Equipment. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.2240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KJE |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |