K253817
- 510(k) number
- K253817
- Device name
- IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
- Applicant
- Immunodiagnostics Systems Limited GB
- Product code
- LLL — Extractable Antinuclear Antibody, Antigen And Contro
- Decision date
- 2026-08-21
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253817.pdf
Official FDA record: K253817
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.