MSW
- Product code
- MSW
- Device name
- System, Test, Thyroglobulin
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 13 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242981 | 2025-06-20 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Thyroglobulin (Tg) | |
| K240927 | 2024-06-28 | Beckman Coulter, Inc. | Access Thyroglobulin | |
| K241423 | 2024-06-07 | Beckman Coulter, Inc. | Access Thyroglobulin | |
| K221890 | 2023-09-30 | Roche Diagnostics | Elecsys Tg II | |
| K220972 | 2023-09-15 | Beckman Coulter, Inc. | Access Thyroglobulin |
Official FDA classification page: MSW
Classification and pathway per current FDA publications. Data from openFDA (CC0).