Source document or public record
FDA 510(k) K232791 — Access Intact PTH
FDA 510(k) index record K232791. Device: Access Intact PTH. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-03-01.
Source
"device_name": "Access Intact PTH"
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 K232791.
Device name: Access Intact PTH. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2024-03-01. Decision wording: Substantially Equivalent.
Product code: CEW. Regulation: 21 CFR 862.1545. 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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