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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 DEN120012
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 Received03/12/2012
Decision Date 05/24/2012
Decision an (AN)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Post-NSE
Reviewed by Third Party No
Combination Product No
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