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FDA 510(k) Application Details - K081483
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K081483
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
TORONTO, ONTARIO M5G 1Y8 CA
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Contact
GLORIA LEE
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
05/28/2008
Decision Date
06/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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