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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 K082675
Device Name STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
Applicant
DIAGNOSTICA STAGO, INC.
5 century dr.
parsippany,  NJ  07054
Contact umberto v parrotta
Regulation Number864.5425
Classification Product Code
JPA  
Date Received09/15/2008
Decision Date 10/10/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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