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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K260331
Device Name IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
Applicant
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy
Caernarfon
Llanberis,  GB LL55 4EL
Applicant Contact Julie Warren
Correspondent
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy
Caernarfon
Llanberis,  GB LL55 4EL
Correspondent Contact Julie Warren
Regulation Number866.5750
Classification Product Code
DHB  
Date Received02/02/2026
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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