Source document or public record
FDA 510(k) K223867 — IDS ACTH II
FDA 510(k) index record K223867. Device: IDS ACTH II. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2023-08-18.
Source
"device_name": "IDS ACTH II"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K223867.
Device name: IDS ACTH II. Applicant as listed: Immunodiagnostic Systems Limited.
Decision date: 2023-08-18. Decision wording: Substantially Equivalent.
Product code: CKG. Regulation: 21 CFR 862.1025. Medical specialty: Clinical Chemistry.
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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