| Device Type ID | 2469 |
| Device Name | Solution, Helly |
| Regulation Description | General Purpose Reagent. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.4010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IFS |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2469 |
| Device | Solution, Helly |
| Product Code | IFS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Reagent. |
| CFR Regulation Number | 864.4010 [🔎] |