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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.
 
DeviceEBK
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN
1951 NORTHWESTERN AVENUE
PO BOX 285
STILLWATER, MN 55082-0285
PMA NumberP870048
Supplement NumberS001
Date Received10/05/1990
Decision Date01/10/1991
Withdrawal Date 09/18/2007
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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