K250408
- 510(k) number
- K250408
- Device name
- Alegria Flash ENA Screen
- Applicant
- Zeus Scientific NJ · US
- Product code
- LLL — Extractable Antinuclear Antibody, Antigen And Contro
- Decision date
- 2025-09-19
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250408
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.