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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namesystem, test, carcinoembryonic antigen
Generic Namesystem, test, carcinoembryonic antigen
Regulation Number866.6010
1080 u.s. hwy. 202
branchburg township
somerville, NJ 08876-3771
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No