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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameAMIKACIN ELUTION DISK FOR AUTOBAC
Classification Namediscs, elution
Generic Nameelution discs
Regulation Number866.1620
ApplicantORGANON TEKNIKA CORP.
PMA NumberN50485
Supplement NumberS017
Date Received10/07/1987
Decision Date04/05/1988
Product Code
LTX[ Registered Establishments with LTX ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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