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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT AXSYM 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 rd.
ap5n-2, dept. 09vb
abbott park, IL 60064-3500
PMA NumberP820060
Supplement NumberS029
Date Received04/21/2011
Decision Date05/12/2011
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE THE SPECIFICATIONS FOR IN- PROCESS TESTING AND CUSTOMER RELEASE TESTING FOR AXSYM AFP AS A RESULT OF AN INTERNAL REVIEW OF THE PRODUCT RELATIVE TO UPDATED SPECIFICATION SETTING PROCEDURES.
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