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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEBK
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Namehbeag and antihbe ria kit
ApplicantDIASORIN
PMA NumberP870048
Date Received08/18/1987
Decision Date07/13/1990
Withdrawal Date 09/18/2007
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 90M-0244
Notice Date 10/01/1990
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S008 
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