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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 NameABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-eia diagnostic kit
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Date Received08/13/1982
Decision Date06/21/1983
Withdrawal Date 11/15/2013
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 83M-0217
Notice Date 07/19/1983
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S019 
S021 S022 S023 S024 S025 S026 S027 S029 S030 
S031 
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