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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 ARCHITECT AFP ASSAY
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
09V6 AP5-2N
100 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064
PMA NumberP120008
Supplement NumberS010
Date Received10/04/2016
Decision Date10/27/2016
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Abbott Laboratories requests approval to transfer the manufacturing and testing of two monoclonal antibodies from one Abbott manufacturing site to another.
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