K250814
- 510(k) number
- K250814
- Device name
- Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
- Applicant
- Zeus Scientific NJ · US
- Product code
- OBE — Anti-Ss-A 52 Autoantibodies
- Decision date
- 2026-05-08
- Date received
- 2025-03-17
- 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: K250814
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.