510(k) clearance

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

FDA 510(k) source

510(k) number

K260331

Applicant

Siemens Healthcare Diagnostics Products, Ltd.

Decision date

Sep 4, 2026

Date received

Feb 2, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DHB

Device type

System, Test, Radioallergosorbent (Rast) Immunological

Device class

Class II

Regulation

21 CFR 866.5750

Advisory committee

Immunology

Statement or summary

Summary

Third party

N

Location

Llanberis, GB