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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade Name9EPANOSTIKA(TM) ANTI-HAV IGM
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameigm antibodies to hepatitis a in serum or plasma
Regulation Number866.3310
ApplicantORGANON TEKNIKA CORP.
PMA NumberP830017
Supplement NumberS001
Date Received08/25/1989
Decision Date03/21/1990
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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