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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.
 
DeviceABBOTT AFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
Abbott Laboratories
100 abbott park road
dept 9va ap6c-2
abbott park, IL 60064
PMA NumberP780005
Date Received10/03/1978
Decision Date06/25/1984
Withdrawal Date 09/12/2007
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 84M-0238
Notice Date 07/25/1984
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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