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510(k) K161317

Sysmex Automated Blood Coagulation Analyzer CS-5100 by Siemens Healthcare Diagnostics Products GmbH — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2016
Date Received
May 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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