JZO
- Product code
- JZO
- Device name
- System, Test, Thyroid Autoantibody
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5870
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 92 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250250 | 2025-10-17 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroid Peroxidase II | |
| K240469 | 2024-08-09 | Beckman Coulter, Inc. | Access TPO Antibody | |
| K213517 | 2023-09-26 | Beckman Coulter, Inc. | Access Thyroglobulin Antibody II | |
| K222610 | 2023-09-15 | Roche Diagnostics | Elecsys Anti-Tg |
Official FDA classification page: JZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).