| Device Type ID | 2315 |
| Device Name | Test, Thromboplastin Generation |
| Regulation Description | Thromboplastin Generation Test. |
| 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 | 864.7900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GKQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2315 |
| Device | Test, Thromboplastin Generation |
| Product Code | GKQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Thromboplastin Generation Test. |
| CFR Regulation Number | 864.7900 [🔎] |