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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 candida species nucleic acid detection system
De Novo Number DEN140019
Device Name T2CANDIDA AND T2DX INSTRUMENT
Requester
t2 biosystems, inc
101 hartwell ave.
lexington,  MA  02421
Contact sarah kalil
Regulation Number866.3960
Classification Product Code
PII  
Date Received05/27/2014
Decision Date 09/22/2014
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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