FDA 510(k) clearance · back to tracker

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

Immunodiagnostics Systems Limited cleared K253817 on 2026-08-21, decision: substantially equivalent

K-number

K253817

Sponsor

Immunodiagnostics Systems Limited

Device

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-21

Product code

LLL

Advisory committee

Immunology

Medical specialty

Immunology

Regulation number

866.5100

Official FDA record

Open K253817on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K253817 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.