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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 NameABBOTT HBE DIAGNOSTIC KIT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Namehbe detection kit
ApplicantABBOTT LABORATORIES
PMA NumberP790025
Date Received10/03/1979
Decision Date07/15/1980
Withdrawal Date 03/22/2007
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 80M-0267
Notice Date 09/12/1980
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S006 S007 S008 
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