AXSYM CORE-M 2.0

FDA Premarket Approval P060009 S005

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

Changes to replace reagents for in- process testing of the hbv core antigen (anti-hbc) specific activity and to allow the use of two alternative precursors for manufacturing of the purified filtered hbc igg within the abbott park, illinois manufacturing facility.

DeviceAXSYM CORE-M 2.0
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantABBOTT LABORATORIES INC
Date Received2011-03-07
Decision Date2011-04-04
PMAP060009
SupplementS005
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: 09vb Bldg: Ap5-2 abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P060009Original Filing
S007 2012-11-13 30-day Notice
S006 2011-11-02 135 Review Track For 30-day Notice
S005 2011-03-07 30-day Notice
S004 2011-01-31 Normal 180 Day Track No User Fee
S003 2010-11-01 Normal 180 Day Track No User Fee
S002 2010-09-27 30-day Notice
S001 2007-01-17 30-day Notice

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