ARCHITECT AFP / Alinity i AFP

FDA Premarket Approval P120008 S021

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.

Pre-market Approval Supplement Details

DeviceARCHITECT AFP / Alinity i AFP
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantAbbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2023-01-06
Decision Date2023-01-27
PMAP120008
SupplementS021
Product CodeLOK 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Laboratories
09v6 Ap5-2n
100 Abbott Park Road
abbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Switch To A New Supplier Of A Noncritical Manufacturing Ingredient

Supplemental Filings

Supplement NumberDateSupplement Type
P120008Original Filing
S021 2023-01-06 30-day Notice
S020 2022-09-14 30-day Notice
S019 2021-11-18 30-day Notice
S018 2021-11-09 30-day Notice
S017 2021-02-09 Real-time Process
S016 2020-10-16 30-day Notice
S015 2020-03-16 Normal 180 Day Track No User Fee
S014 2020-03-16 Normal 180 Day Track No User Fee
S013
S012 2018-11-13 30-day Notice
S011
S010 2016-10-04 30-day Notice
S009 2015-07-16 30-day Notice
S008 2015-06-15 30-day Notice
S007 2014-11-13 30-day Notice
S006 2014-03-18 30-day Notice
S005 2013-10-30 30-day Notice
S004 2013-10-28 30-day Notice
S003 2013-05-13 30-day Notice
S002 2013-02-19 Normal 180 Day Track
S001 2013-02-11 30-day Notice

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