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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 ANTIBODY TO HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP970027
Supplement NumberS005
Date Received01/17/2007
Decision Date02/05/2007
Withdrawal Date11/08/2013
Product Code MZO 
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
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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