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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, c-reactive protein
510(k) Number K221119
Device Name RCRP Flex reagent cartridge
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Ian Thompson
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Ian Thompson
Regulation Number866.5270
Classification Product Code
DCN  
Date Received04/18/2022
Decision Date 03/17/2023
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
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