| Device Type ID | 257 |
| Device Name | Radioimmunoassay, Total Thyroxine |
| Regulation Description | Total Thyroxine Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CDX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 257 |
| Device | Radioimmunoassay, Total Thyroxine |
| Product Code | CDX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Thyroxine Test System. |
| CFR Regulation Number | 862.1700 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 23 |
Low Test Results | 3 |
Incorrect Or Inadequate Test Results | 3 |
Non Reproducible Results | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 32 |