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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K212559
Device Name CardioPhase® hsCRP
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring St. 76
Marburg,  DE 35041
Applicant Contact Martina Pfeiff
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring St. 76
Marburg,  DE 35041
Correspondent Contact Martina Pfeiff
Regulation Number866.5270
Classification Product Code
NQD  
Date Received08/13/2021
Decision Date 12/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
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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