510(k) clearance
Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- 510(k) number
- K261466
- Applicant
- Zeus Scientific
- Decision date
- Aug 21, 2026
- Date received
- May 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MOB
- Device type
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class II
- Regulation
- 21 CFR 866.5660
- Advisory committee
- Immunology
- Statement or summary
- Summary
- Third party
- N
- Location
- Branchburg, NJ, US