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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K151867
Device Name STA R MAX
Applicant
DIAGNOSTICA STAGO S.A.S.
125 AVENUE LOUIS ROCHE
GENNEVILLIERS,  FR 92230
Applicant Contact ARNAUD COLLIN
Correspondent
DIAGNOSTICA STAGO, INCORPORATED
5 CENTURY DRIVE
PARSIPPANY,  NJ  07054
Correspondent Contact JAMES MONROE
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/09/2015
Decision Date 08/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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