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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 K973819
Device Name VIDAS D-DIMER (DD) ASSAY
Applicant
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact TERRY MCGOVERN
Correspondent
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact TERRY MCGOVERN
Regulation Number864.7320
Classification Product Code
DAP  
Date Received10/07/1997
Decision Date 03/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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