510(k) K250814
- Device
- Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
- Applicant
- Zeus Scientific
- 510(k) number
- K250814
- Product code
- OBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-08
- Date received
- 2025-03-17
- Regulation
- 866.5100
- Classification name
- Anti-Ss-A 52 Autoantibodies
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daniel Zweitzig
- Address
- 200 Evans Way Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 2026994
- 3012348571
Source Documents#
510(k) summary PDF not indicated by FDA