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FDA 510(k) Application Details - DEN050004
Device Classification Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
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510(K) Number
DEN050004
Device Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant
TM BIOSCIENCE CORPORATION
439 UNIVERSITY AVE., SUITE 900
TORONTO, ONTARIO M5G 1Y8 CA
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NANCY KRUNIC
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Regulation Number
866.5900
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Classification Product Code
NUA
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Date Received
04/05/2005
Decision Date
05/09/2005
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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