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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
Generic NameKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Regulation Number866.6010
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP820060
Supplement NumberS019
Date Received08/14/2003
Decision Date02/02/2004
Withdrawal Date11/15/2013
Product Code LOJ 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.
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