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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.
 
DeviceABBOTT CEA-EIA
Generic NameSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Regulation Number866.6010
ApplicantAbbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP830066
Supplement NumberS006
Date Received02/11/1988
Decision Date03/28/1988
Product Code DHX 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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