FDA Premarket Approval P120008 S016

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

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

DeviceARCHITECT AFP and Alinity i AFP
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantAbbott Laboratories
Date Received2020-10-16
Decision Date2020-11-05
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
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
S012 2018-11-13 30-day Notice
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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