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510(k) K151964

Xprecia Stride Coagulation System, Xprecia System PT Controls by Siemens Healthcare Diagnostics — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2016
Date Received
July 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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