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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameARCHITECT HBSAG AND HBSAG CONFIRMATORY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP060007
Supplement NumberS001
Date Received09/22/2006
Decision Date10/18/2006
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of specifications, the modification of specifications, and additional testing during the manufacturing process.
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