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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 K990774
Device Name ABBOTT ARCHITECT CEA
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact KAREN L GATES
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact KAREN L GATES
Regulation Number866.6010
Classification Product Code
DHX  
Date Received03/09/1999
Decision Date 05/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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