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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K161317
Device Name Sysmex Automated Blood Coagulation Analyzer CS-5100
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
Marburg,  DE 35041
Applicant Contact Nils Neumann
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
Marburg,  DE
Correspondent Contact Nils Neumann
Regulation Number864.5425
Classification Product Code
JPA  
Date Received05/11/2016
Decision Date 09/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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