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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K171566
Device Name Atellica IM High-Sensitivity Troponin I (TNIH)
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Matthew Gee
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Matthew Gee
Regulation Number862.1215
Classification Product Code
MMI  
Date Received05/30/2017
Decision Date 07/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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