Source document or public record
FDA 510(k) K260049 — Elecsys Anti-HBc IgM
FDA 510(k) index record K260049. Device: Elecsys Anti-HBc IgM. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-07.
Source
"device_name": "Elecsys 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
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FDA 510(k) public index record K260049.
Device name: Elecsys Anti-HBc IgM. Applicant as listed: Roche Diagnostics.
Decision date: 2026-04-07. 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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