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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 NameHEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Namehbeag/anti hbe
ApplicantORGANON TEKNIKA CORP.
PMA NumberP840070
Date Received12/26/1984
Decision Date05/14/1986
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 86M-0238
Notice Date 07/01/1986
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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