ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit

FDA Premarket Approval P120008 S017

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

Approval to modify the architect i1000sr probe wash with an alternate wash delivery system (awds), and to modify the architect i2000sr and alinity i with induction heating (ih)

DeviceARCHITECT AFP Reagents, Alinity i AFP Reagent Kit
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantAbbott Laboratories
Date Received2021-02-09
Decision Date2021-04-22
PMAP120008
SupplementS017
Product CodeLOK 
Advisory CommitteeImmunology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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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