Source document or public record
FDA 510(k) K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
FDA 510(k) index record K253817. Device: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La. Applicant as listed: Immunodiagnostics Systems Limited. Decision date: 2026-08-21.
Source
"device_name": "IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K253817.
Device name: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La. Applicant as listed: Immunodiagnostics Systems Limited.
Decision date: 2026-08-21. Decision wording: Substantially Equivalent.
Product code: LLL. Regulation: 21 CFR 866.5100. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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