MOB
- Product code
- MOB
- Device name
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 75 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261466 | 2026-08-21 | Zeus Scientific | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash … | |
| K243776 | 2025-05-07 | Zeus Scientific | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixe… | — |
Official FDA classification page: MOB
Classification and pathway per current FDA publications. Data from openFDA (CC0).