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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K063765
Device Name ID-TAG RESPIRATORY VIRAL PANEL
Original Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario,  CA m5g 1y8
Original Contact gloria lee
Regulation Number866.3980
Classification Product Code
OCC  
Date Received01/08/2007
Decision Date 01/03/2008
Decision de novo petitions granted (AN)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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