JNL
- Product code
- JNL
- Device name
- Immunochemical, Thyroglobulin 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)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 22 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250816 | 2025-12-04 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | |
| K240996 | 2024-07-03 | Beckman Coulter, Inc. | Access Thyroglobulin Antibody II |
Official FDA classification page: JNL
Classification and pathway per current FDA publications. Data from openFDA (CC0).