Source document or public record
FDA 510(k) K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
FDA 510(k) index record K233663. Device: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2023-12-13.
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"device_name": "N Antisera to Human Immunoglobulins (IgG, IgA, and 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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2026-10-20
2026-10-20
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FDA 510(k) public index record K233663.
Device name: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH.
Decision date: 2023-12-13. Decision wording: Substantially Equivalent.
Product code: CFN. Regulation: 21 CFR 866.5510. 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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