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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, 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 NumberS023
Date Received05/26/2023
Decision Date06/22/2023
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  
Addition of a new fill line in existing manufacturing space.
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