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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCEA-ROCHE(R) EIA
Classification Namesystem, test, carcinoembryonic antigen
Generic Namesystem, test, carcinoembryonic antigen
Regulation Number866.6010
Applicant
ROCHE DIAGNOSTICS GMBH
1080 u.s. hwy. 202
branchburg township
somerville, NJ 08876-3771
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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