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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCEA-ROCHE(R) EIA
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecarcinoembryonic antigen test system
Regulation Number866.6010
ApplicantHOFFMANN-LA ROCHE, INC.
PMA NumberP840027
Supplement NumberS002
Date Received08/19/1986
Decision Date02/19/1987
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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