Source document or public record
FDA 510(k) K254059 — Access anti-HBc IgM
FDA 510(k) index record K254059. Device: Access anti-HBc IgM. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-03-13.
Source
"device_name": "Access anti-HBc IgM"
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
professional use
FDA 510(k) public index record K254059.
Device name: Access anti-HBc IgM. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2026-03-13. Decision wording: Substantially Equivalent.
Product code: SEI. Regulation: 21 CFR 866.3173. Medical specialty: Microbiology.
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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