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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCEA-RIA MONOCLONAL
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecea-eia
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP830066
Supplement NumberS001
Date Received12/16/1983
Decision Date08/21/1984
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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