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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 K093001
Device Name STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
Applicant
DIAGNOSTICA STAGO, INCORPORATED
5 CENTURY DRIVE
PARSIPPPANY,  NJ  07054
Applicant Contact UMBERTO V PARROTTA
Correspondent
DIAGNOSTICA STAGO, INCORPORATED
5 CENTURY DRIVE
PARSIPPPANY,  NJ  07054
Correspondent Contact UMBERTO V PARROTTA
Regulation Number864.5425
Classification Product Code
JPA  
Date Received09/28/2009
Decision Date 12/18/2009
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
Predetermined Change
Control Plan Authorized		 No
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