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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.
 
DeviceHEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
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
ORGANON TEKNIKA CORP.
100 akzo ave.
durham, NC 27712
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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