AXSYM CORE 2.0

FDA Premarket Approval P060012 S002

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

Change to the matching test procedure to allow optimization of microparticle percent solids based on a target index calibrator signal rate count.

DeviceAXSYM CORE 2.0
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantABBOTT LABORATORIES INC
Date Received2010-05-19
Decision Date2010-06-03
PMAP060012
SupplementS002
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 ap5n-2, Dept. 09vb abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P060012Original Filing
S010 2012-11-13 30-day Notice
S009 2011-11-02 135 Review Track For 30-day Notice
S008 2011-09-07 Special (immediate Track)
S007 2011-03-21 135 Review Track For 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 2010-09-21 30-day Notice
S002 2010-05-19 30-day Notice
S001 2007-01-17 30-day Notice

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