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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCEA-ROCHE(R) EIA
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecea-eia
Regulation Number866.6010
ApplicantROCHE DIAGNOSTICS GMBH
PMA NumberP840027
Date Received06/19/1984
Decision Date05/13/1985
Withdrawal Date 09/27/2007
Product Code
DHX[ Registered Establishments with DHX ]
Docket Number 85M-0253
Notice Date 06/12/1985
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
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