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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.
 
DeviceOPUS(R) CEA TEST SYSTEM
Generic NameSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Regulation Number866.6010
ApplicantBehring Diagnostics, Inc.
151 University Ave.
Westwood, MA 02090
PMA NumberP920021
Supplement NumberS001
Date Received07/03/1995
Decision Date02/23/1996
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
Approval Order Statement  
APPROVAL TO ADD THE CEA TEST SYSTEM TO THE OPUS PLUS AND OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS
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