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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, carcinoembryonic antigen
510(k) Number K071603
Device Name DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
Applicant
DADE BEHRING, INC.
GLASGOW SITE, PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
DADE BEHRING, INC.
GLASGOW SITE, PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.6010
Classification Product Code
DHX  
Subsequent Product Code
JIX  
Date Received06/12/2007
Decision Date 06/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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