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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K233663
Device Name N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg,  DE 35041
Applicant Contact Sanja Matern
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg,  DE 35041
Correspondent Contact Sanja Matern
Regulation Number866.5510
Classification Product Code
CFN  
Date Received11/15/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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