| Device Type ID | 2368 |
| Device Name | Test, Erythrocyte Sedimentation Rate |
| Regulation Description | Erythrocyte Sedimentation Rate 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 | 864.6700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JPH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2368 |
| Device | Test, Erythrocyte Sedimentation Rate |
| Product Code | JPH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Erythrocyte Sedimentation Rate Test. |
| CFR Regulation Number | 864.6700 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 1 |
Fluid Leak | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Integrity Problem | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 6 |