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FDA 510(k) Application Details - K163347
Device Classification Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
More FDA Info for this Device
510(K) Number
K163347
Device Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave
Toronto M5g1y8 CA
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Contact
Tina Ip
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Regulation Number
866.5900
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Classification Product Code
NUA
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More FDA Info for this Product Code
Date Received
11/28/2016
Decision Date
12/15/2016
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MG -
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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