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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 K161556
Device Name CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
Applicant
Centers for Disease Control and Prevention (CDC)
1600 Clifton, MS-C18
Atlanta,  GA  30329 -4027
Applicant Contact Yon Yu
Correspondent
Centers for Disease Control and Prevention (CDC)
1600 Clifton, MS-C18
Atlanta,  GA  30329 -4027
Correspondent Contact Yon Yu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD   OEP   OQW  
Date Received06/06/2016
Decision Date 06/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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