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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K151964
FOIA Releasable 510(k) K151964
Device Name Xprecia Stride Coagulation System, Xprecia System PT Controls
Applicant
Siemens Healthcare Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Applicant Contact NOOR MALKI
Correspondent
Siemens Healthcare Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Correspondent Contact NOOR MALKI
Regulation Number864.7750
Classification Product Code
GJS  
Subsequent Product Code
GGN  
Date Received07/16/2015
Decision Date 09/30/2016
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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