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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 dengue nucleic acid amplification assay (naat)
De Novo Number DEN120012
510(K) Number K113336
Device Name CDC DENV-1-4 REAL TIME RT-PCT ASSAY
Requester
centers for disease control and prevention
1600 clifton rd., ne
atlanta,  GA  30333
Contact hye-joo kim
Regulation Number866.3946
Classification Product Code
OZB  
Date Received03/12/2012
Decision Date 05/24/2012
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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