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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 DRIVE
NORWOOD,  MA  02062
Applicant Contact NOOR MALKI
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  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
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