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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 K063356
Device Name STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number864.7320
Classification Product Code
DAP  
Date Received11/07/2006
Decision Date 03/23/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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