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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 NameIMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core antigen (ant0hbc igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP010051
Supplement NumberS007
Date Received11/02/2009
Decision Date01/20/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at siemens healthcare diagnostics, newark, delaware for immulite substrate manufacturing.
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