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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name respiratory virus panel nucleic acid assay system
De Novo Number DEN070013
510(K) Number K063765
Device Name ID-TAG RESPIRATORY VIRAL PANEL
Requester
luminex molecular diagnostics, inc.
439 university ave.
toronto, ontario,  CA m5g 1y8
Contact gloria lee
Regulation Number866.3980
Classification Product Code
OCC  
Date Received12/04/2007
Decision Date 01/03/2008
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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