ABBOTT ARCHITECT AFP ASSAY

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P120008 S010

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

Abbott laboratories requests approval to transfer the manufacturing and testing of two monoclonal antibodies from one abbott manufacturing site to another.

DeviceABBOTT ARCHITECT AFP ASSAY
Classification NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantAbbott Laboratories
Date Received2016-10-04
Decision Date2016-10-27
PMAP120008
SupplementS010
Product CodeLOK
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 09v6 Ap5-2n 100 Abbott Park Road abbott Park, IL 60064

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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