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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceTRUQUANT(R) BR(TM) RIA
Generic NameANTIGEN, CANCER 549
ApplicantBiomira, Inc.
30 Meridian Rd.
Rexdale, Ontario M9W 4
PMA NumberP950011
Date Received02/28/1995
Decision Date03/29/1996
Product Code MJB 
Docket Number 96M-0216
Notice Date 07/23/1996
Advisory Committee Immunology
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN IN VITRO DIAGNOSITC DEVICE (BIOMIRA TRUQUANT BR RIA)
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