IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)— 510(k) K260331

Name: FDA 510(k) clearance K260331
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) clearance K260331 for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13), Substantially Equivalent on 2026-09-04. Applicant: Siemens Healthcare Diagnostics Products, Ltd.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products, Ltd.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 2026-02-02
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanberis, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.