Source document or public record
FDA 510(k) K200475 — IDS-iSYS Ostase BAP
FDA 510(k) index record K200475. Device: IDS-iSYS Ostase BAP. Applicant as listed: Immunodiagnostic Systems , Ltd.. Decision date: 2020-09-30.
Source
"device_name": "IDS-iSYS Ostase BAP"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K200475.
Device name: IDS-iSYS Ostase BAP. Applicant as listed: Immunodiagnostic Systems , Ltd..
Decision date: 2020-09-30. Decision wording: Substantially Equivalent.
Product code: CIN. Regulation: 21 CFR 862.1050. 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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