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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fibrinogen and fibrin split products, antigen, antiserum, control
510(k) Number K112818
Device Name VIDAS D-DIMER EXCLUSION II (DEX2)
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Original Contact veronica daenzer
Regulation Number864.7320
Classification Product Code
DAP  
Date Received09/28/2011
Decision Date 07/31/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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