Source document or public record
FDA 510(k) K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
FDA 510(k) index record K260331. Device: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13). Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2026-09-04.
Source
"device_name": "IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)"
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 K260331.
Device name: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13). Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd..
Decision date: 2026-09-04. Decision wording: Substantially Equivalent.
Product code: DHB. Regulation: 21 CFR 866.5750. 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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