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510(k) K172286

Automated Blood Coagulation Analyzer CS-2500 by Siemens Healthcare Diagnostic Products GmbH — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2017
Date Received
July 28, 2017
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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