ARCHITECT AUSAB and Alinity i Anti-HBs

FDA Premarket Approval P050051 S040

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 AUSAB and Alinity i Anti-HBs
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantABBOTT LABORATORIES INC
Date Received2020-10-16
Decision Date2020-11-05
PMAP050051
SupplementS040
Product CodeLOM 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap8-1 abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P050051Original Filing
S040 2020-10-16 30-day Notice
S039 2020-03-16 Normal 180 Day Track No User Fee
S038 2020-03-16 Normal 180 Day Track No User Fee
S037
S036 2019-11-04 30-day Notice
S035 2019-06-10 30-day Notice
S034 2018-10-16 30-day Notice
S033 2017-12-21 Normal 180 Day Track
S032 2016-08-22 Normal 180 Day Track
S031 2016-06-14 30-day Notice
S030 2015-07-16 30-day Notice
S029 2014-12-04 30-day Notice
S028 2014-11-13 30-day Notice
S027 2014-10-03 30-day Notice
S026 2014-03-18 30-day Notice
S025 2013-12-20 30-day Notice
S024 2013-10-30 30-day Notice
S023 2013-10-28 30-day Notice
S022 2013-09-24 30-day Notice
S021 2013-06-21 30-day Notice
S020 2013-02-11 30-day Notice
S019 2012-11-19 30-day Notice
S018 2012-11-15 30-day Notice
S017 2012-11-13 30-day Notice
S016 2012-11-01 30-day Notice
S015 2012-08-03 30-day Notice
S014 2011-11-23 Special (immediate Track)
S013 2011-05-25 30-day Notice
S012 2011-05-04 Normal 180 Day Track No User Fee
S011 2011-04-18 30-day Notice
S010 2011-02-25 30-day Notice
S009 2011-02-17 Normal 180 Day Track No User Fee
S008 2010-12-22 Special (immediate Track)
S007 2010-11-22 Normal 180 Day Track No User Fee
S006 2010-11-01 Normal 180 Day Track No User Fee
S005 2010-08-23 Normal 180 Day Track No User Fee
S004 2009-02-12 Normal 180 Day Track
S003 2008-09-29 Real-time Process
S002 2007-10-19 Real-time Process
S001 2006-06-15 135 Review Track For 30-day Notice

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