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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 NameABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP060007
Supplement NumberS002
Date Received01/30/2009
Decision Date07/13/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the application of the architect hbsag/ architect hbsag confirmatory assay, currently approved for use on the abbott architect i2000/i2000sr, onto a new architect i system family member, the architect i 1000sr.
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