ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY

FDA Premarket Approval P050049 S007

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

Addition of an hbsag positive plasma supplier and a change to quality control testing.

DeviceABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantABBOTT LABORATORIES INC
Date Received2011-06-10
Decision Date2011-07-01
PMAP050049
SupplementS007
Product CodeLOM 
Advisory CommitteeMicrobiology
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
P050049Original Filing
S011 2012-11-13 30-day Notice
S010 2012-02-06 30-day Notice
S009 2011-11-02 135 Review Track For 30-day Notice
S008 2011-08-01 135 Review Track For 30-day Notice
S007 2011-06-10 30-day Notice
S006 2011-01-31 Normal 180 Day Track No User Fee
S005 2010-11-01 Normal 180 Day Track No User Fee
S004 2010-09-27 30-day Notice
S003 2008-10-24 Real-time Process
S002 2007-12-13 Special (immediate Track)
S001 2007-01-17 30-day Notice

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