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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, Immunological, Antigen, Tumor
510(k) Number K233946
Device Name IMMULITE® 2000 BR-MA
Applicant
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy, Llanberis
Caernarfon
Llanberis,  GB LL55 4EL
Applicant Contact Karlyn Kellogg
Correspondent
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy, Llanberis
Caernarfon
Llanberis,  GB LL55 4EL
Correspondent Contact Karlyn Kellogg
Regulation Number866.6010
Classification Product Code
MOI  
Date Received12/14/2023
Decision Date 03/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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