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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEBK
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
DIASORIN
1951 northwestern avenue
po box 285
stillwater, MN 55082-0285
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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