Alinity i Anti-HBc IgM (List Number 07P86)

FDA Premarket Approval P060035 S036

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

DeviceAlinity i Anti-HBc IgM (List Number 07P86)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-27
Decision Date2022-10-25
PMAP060035
SupplementS036
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Laboratories
100 Abbott Park Rd.
ap5n-2, Dept. 09vb
abbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of A New Fill Line In Existing Manufacturing Space

Supplemental Filings

Supplement NumberDateSupplement Type
P060035Original Filing
S036 2022-09-27 30-day Notice
S035 2022-09-14 30-day Notice
S034 2021-11-18 30-day Notice
S033 2021-11-09 30-day Notice
S032 2021-02-09 Real-time Process
S031
S030 2020-03-16 Normal 180 Day Track No User Fee
S029 2020-03-16 Normal 180 Day Track No User Fee
S028
S027 2018-10-22 30-day Notice
S026 2018-06-01 Normal 180 Day Track
S025 2015-07-16 30-day Notice
S024 2014-11-13 30-day Notice
S023 2014-09-19 30-day Notice
S022 2013-10-30 30-day Notice
S021 2013-10-28 30-day Notice
S020 2013-02-15 30-day Notice
S019 2013-02-11 30-day Notice
S018 2012-11-19 30-day Notice
S017 2012-11-15 30-day Notice
S016 2012-11-13 30-day Notice
S015 2012-11-01 30-day Notice
S014 2012-08-03 30-day Notice
S013 2011-11-23 Special (immediate Track)
S012 2011-10-28 30-day Notice
S011 2011-10-28 135 Review Track For 30-day Notice
S010 2011-09-07 Special (immediate Track)
S009 2011-05-25 30-day Notice
S008 2011-05-04 Normal 180 Day Track No User Fee
S007 2011-04-18 30-day Notice
S006 2011-02-17 Normal 180 Day Track No User Fee
S005 2011-01-10 135 Review Track For 30-day Notice
S004 2010-12-22 Special (immediate Track)
S003 2010-11-01 Normal 180 Day Track No User Fee
S002 2010-08-02 Normal 180 Day Track No User Fee
S001 2009-01-08 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380740011154 P060035 001
00380740011147 P060035 001
00380740011130 P060035 001
00380740146177 P060035 026
00380740145187 P060035 026
00380740130282 P060035 026

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