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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.
 
DeviceAFP RIA KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
ALERE, INC.
10 southgate road
scarborough, ME 04074
PMA NumberP760001
Date Received12/16/1976
Decision Date01/13/1984
Withdrawal Date 07/20/2011
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 84M-0031
Notice Date 02/17/1984
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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