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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.
 
DeviceARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
DEPT 09V6, BLDG. AP5-2
ABBOTT PARK, IL 60064-6088
PMA NumberP110029
Supplement NumberS010
Date Received11/19/2012
Decision Date12/14/2012
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
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