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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceAXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories, Inc.
100 Abbott Park Rd.
Dept. 9va-Ap8-1
Abbott Park, IL 60064
PMA NumberP050049
Supplement NumberS003
Date Received10/24/2008
Decision Date12/17/2008
Withdrawal Date11/15/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE OF ASSAY FILES THAT MONITOR LIQUID LEVELS.
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