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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.
 
DeviceDEVICE: ABBOTT AXSYM HAVAB-M 2.0
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49c, Bldg. Ap6c
100 Abbott Park Rd.
Abbott Park North, IL 60064
PMA NumberP790019
Supplement NumberS018
Date Received05/21/2004
Decision Date06/16/2004
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
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