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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K201496
Device Name N Latex FLC kappa, N Latex FLC lambda
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str.- 76
Marburg,  DE 35041
Applicant Contact Christine Perkins
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str.- 76
Marburg,  DE 35041
Correspondent Contact Kerstin Koenigs
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received06/05/2020
Decision Date 10/29/2021
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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