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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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
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
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