ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P110029 S023

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

Relocation of manufacturing activities for the purification and production of antibodies used in final test components.

DeviceARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories
Date Received2016-03-10
Decision Date2016-04-06
PMAP110029
SupplementS023
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 100 Abbott Park Rd. dept 09v6, Bldg. Ap5-2 abbott Park, IL 60064-6088

Supplemental Filings

Supplement NumberDateSupplement Type
P110029Original Filing
S041 2023-01-06 30-day Notice
S040 2022-11-07 30-day Notice
S039 2022-09-14 30-day Notice
S038 2022-09-09 30-day Notice
S037 2022-07-18 30-day Notice
S036 2021-11-18 30-day Notice
S035 2021-11-09 30-day Notice
S034 2021-02-09 Real-time Process
S033 2020-07-02 30-day Notice
S032 2020-03-16 Normal 180 Day Track No User Fee
S031 2020-03-16 Normal 180 Day Track No User Fee
S030
S029 2019-08-01 Normal 180 Day Track
S028 2018-10-16 30-day Notice
S027 2018-06-27 30-day Notice
S026 2017-06-30 Real-time Process
S025
S024 2016-10-14 30-day Notice
S023 2016-03-10 30-day Notice
S022 2015-07-16 30-day Notice
S021 2015-06-15 30-day Notice
S020 2014-12-04 30-day Notice
S019 2014-11-14 30-day Notice
S018 2014-11-13 30-day Notice
S017 2014-03-18 30-day Notice
S016 2013-11-01 30-day Notice
S015 2013-10-30 30-day Notice
S014 2013-10-28 30-day Notice
S013 2013-09-24 30-day Notice
S012 2013-07-17 30-day Notice
S011 2013-02-11 30-day Notice
S010 2012-11-19 30-day Notice
S009 2012-11-15 30-day Notice
S008 2012-11-13 30-day Notice
S007 2012-11-01 30-day Notice
S006 2012-10-26 30-day Notice
S005 2012-09-17 30-day Notice
S004 2012-08-17 30-day Notice
S003 2012-08-03 30-day Notice
S002 2012-06-06 30-day Notice
S001 2012-05-01 Normal 180 Day Track

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