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FDA 510(k) Application Details - K112199
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K112199
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
SUITE 900
TORONTO, ONTARIO M5G 1Y8 CA
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Contact
LUBNA SYED
Other 510(k) Applications for this Contact
Regulation Number
866.3980
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Classification Product Code
OCC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2011
Decision Date
09/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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