| Device Type ID | 2277 |
| Device Name | Hematocrit, Tube, Rack, Sealer, Holder |
| Regulation Description | Hematocrit Measuring Device. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.6400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GHY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2277 |
| Device | Hematocrit, Tube, Rack, Sealer, Holder |
| Product Code | GHY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hematocrit Measuring Device. |
| CFR Regulation Number | 864.6400 [🔎] |