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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameTANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecea immunoradiometric assay
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP840019
Supplement NumberS003
Date Received08/23/1985
Decision Date03/06/1986
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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