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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) ANTI-HAV MIDROELISA SYSTEM
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibodies to hepatitis a virus in serum or plasma
Regulation Number866.3310
ApplicantORGANON TEKNIKA CORP.
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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