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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name influenza a and influenza b multiplex nucleic acid assay
510(k) Number K132508
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Original Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd., n.e.
mailstop c-18
atlanta,  GA  30333
Original Contact hye-joo kim, pharm.d.
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD   OEP   OQW  
Date Received08/12/2013
Decision Date 09/23/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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