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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceOSI TRANSPROBE-1
Generic NameDNA-probe, human chromosome
ApplicantOsi Pharmaceuticals, Inc.
1 Bioscience Park Dr.
Farmingdale, NY 11735
PMA NumberP880045
Date Received06/21/1988
Decision Date10/03/1989
Withdrawal Date06/08/2011
Product Code MAO 
Docket Number 89M-0457
Notice Date 11/14/1989
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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