Source document or public record
FDA 510(k) K220178 — Total Immunoglobulin E (IgE)
FDA 510(k) index record K220178. Device: Total Immunoglobulin E (IgE). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2022-03-23.
Source
"device_name": "Total Immunoglobulin E (IgE)"
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 K220178.
Device name: Total Immunoglobulin E (IgE). Applicant as listed: Beckman Coulter, Inc..
Decision date: 2022-03-23. Decision wording: Substantially Equivalent.
Product code: DGC. 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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