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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 CORE
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP080023
Supplement NumberS006
Date Received02/17/2011
Decision Date03/22/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at abbott ireland diagnostics division in sligo, ireland.
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