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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dengue nucleic acid amplification assay (naat)
510(k) Number K113336
Device Name CDC DENV-1-4 REAL TIME RT-PCT ASSAY
Original Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd., n.e.
atlanta,  GA  30333
Original Contact hye-joo kim
Regulation Number866.3946
Classification Product Code
OZB  
Date Received11/14/2011
Decision Date 05/24/2012
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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