ABBOTT AXSYM AUSAB

FDA Premarket Approval P060003 S009

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

Approval for modifications to the quality control test methods.

DeviceABBOTT AXSYM AUSAB
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantABBOTT LABORATORIES INC
Date Received2011-03-21
Decision Date2011-05-13
PMAP060003
SupplementS009
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type135 Review Track For 30-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- Ap5-2 abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P060003Original Filing
S012 2012-11-13 30-day Notice
S011 2011-11-02 135 Review Track For 30-day Notice
S010 2011-09-06 30-day Notice
S009 2011-03-21 135 Review Track For 30-day Notice
S008 2011-01-31 Normal 180 Day Track No User Fee
S007 2010-11-01 Normal 180 Day Track No User Fee
S006 2010-09-27 30-day Notice
S005 2010-06-11 Real-time Process
S004 2009-02-17 30-day Notice
S003 2007-01-17 30-day Notice
S002 2006-09-05 30-day Notice
S001 2006-08-15 30-day Notice

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