Source document or public record
FDA 510(k) K252580 — iQ200 Series
FDA 510(k) index record K252580. Device: iQ200 Series. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-09-10.
Source
"device_name": "iQ200 Series"
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 K252580.
Device name: iQ200 Series. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2025-09-10. Decision wording: Substantially Equivalent.
Product code: LKM. Regulation: 21 CFR 864.5200. Medical specialty: Hematology.
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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