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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)
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact VERONICA DAENZER
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact VERONICA DAENZER
Regulation Number864.7320
Classification Product Code
DAP  
Date Received09/28/2011
Decision Date 07/31/2012
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
Recalls CDRH Recalls
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