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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.
 
DeviceARCHITECT AFP and Alinity i AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
09v6 Ap5-2n
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP120008
Supplement NumberS016
Date Received10/16/2020
Decision Date11/05/2020
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.
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