K261466
- 510(k) number
- K261466
- Device name
- Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- Applicant
- Zeus Scientific NJ · US
- Product code
- MOB — Test System, Antineutrophil Cytoplasmic Antibodies (
- Decision date
- 2026-08-21
- Date received
- 2026-05-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K261466.pdf
Official FDA record: K261466
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.