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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 CORE 2.0 & AXSYM CORE 2.0 CONTROLS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories, Inc.
100 Abbott Park Rd.
Ap5n-2, Dept 09vb
Abbott Park, IL 60064
PMA NumberP060012
Supplement NumberS001
Date Received01/17/2007
Decision Date02/05/2007
Withdrawal Date11/15/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
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