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.
Approval for a manufacturing site located at abbott ireland diagnostics division in sligo, ireland.
Device | ARCHITECT AUSAB |
Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Applicant | ABBOTT LABORATORIES INC |
Date Received | 2011-02-17 |
Decision Date | 2011-03-22 |
PMA | P050051 |
Supplement | S009 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap8-1 abbott Park, IL 60064 |
Supplement Number | Date | Supplement Type |
---|---|---|
P050051 | Original Filing | |
S049 | 2023-01-06 | 30-day Notice |
S048 | 2022-11-07 | 30-day Notice |
S047 | 2022-09-14 | 30-day Notice |
S046 | 2022-09-09 | 30-day Notice |
S045 | 2021-11-18 | 30-day Notice |
S044 | 2021-11-09 | 30-day Notice |
S043 | ||
S042 | 2021-08-11 | 30-day Notice |
S041 | 2021-02-09 | Real-time Process |
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 |