| Device Type ID | 5997 |
| Device Name | Cyclosporine Radioimmunoassay |
| Regulation Description | Cyclosporine Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1235 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LTB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5997 |
| Device | Cyclosporine Radioimmunoassay |
| Product Code | LTB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cyclosporine Test System. |
| CFR Regulation Number | 862.1235 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 1 |
High Test Results | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |