| Device Type ID | 3051 |
| Device Name | System, Test, Thyroglobulin |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MSW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3051 |
| Device | System, Test, Thyroglobulin |
| Product Code | MSW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Break | 3 |
Mechanical Problem | 2 |
High Test Results | 2 |
Device Operates Differently Than Expected | 2 |
Unstable | 1 |
Use Of Device Problem | 1 |
Insufficient Information | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Sharp Edges | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Jun-28-2017 |
| 2 | Beckman Coulter Inc. | II | Sep-03-2015 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |