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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameABBOTT CEA-RIA MONOCLONAL
Classification Namesystem, test, carcinoembryonic antigen
Generic Nameabbott cea-ria monoclonal assay
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP830066
Supplement NumberS012
Date Received06/14/1995
Decision Date07/12/1995
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the package labeling to decrease the "hook" value from 100,00 to 60,000 ng cea/ml.
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