LLL
- Product code
- LLL
- Device name
- Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5100
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 182 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253817 | 2026-08-21 | Immunodiagnostics Systems Limited | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | |
| K253367 | 2026-06-25 | Phadia AB | EliA CTD 13 Screen | |
| K250666 | 2025-10-22 | Zeus Scientific | Alegria Flash CTD Screen | — |
| K250408 | 2025-09-19 | Zeus Scientific | Alegria Flash ENA Screen | — |
| K213403 | 2023-09-29 | Inova Diagnostics, Inc. | Aptiva CTD Essential Reagent |
Official FDA classification page: LLL
Classification and pathway per current FDA publications. Data from openFDA (CC0).