Source document or public record
FDA 510(k) K231832 — Access Myoglobin
FDA 510(k) index record K231832. Device: Access Myoglobin. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-09-18.
Source
"device_name": "Access Myoglobin"
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 K231832.
Device name: Access Myoglobin. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2023-09-18. Decision wording: Substantially Equivalent.
Product code: DDR. Regulation: 21 CFR 866.5680. Medical specialty: Immunology.
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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