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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 NumberS001
Date Received06/17/1986
Decision Date09/08/1986
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No