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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 K153148
Device Name CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
1600 CLIFTON ROAD, MS-C18
atlanta,  GA  30329 -4027
Applicant Contact yon yu
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
1600 CLIFTON ROAD, MS-C18
atlanta,  GA  30329 -4027
Correspondent Contact yon yu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD  
Date Received10/30/2015
Decision Date 12/01/2015
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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