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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) ANTI-HAV MIDROELISA SYSTEM
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Applicant
ORGANON TEKNIKA CORP.
100 akzo ave.
durham, NC 27712
PMA NumberP830018
Date Received04/05/1983
Decision Date02/06/1989
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 89M-0057
Notice Date 04/17/1989
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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