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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 K020810
Device Name VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact SANDRA PERREAND
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact SANDRA PERREAND
Regulation Number864.7320
Classification Product Code
DAP  
Date Received03/13/2002
Decision Date 10/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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