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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 K141859
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON ROAD, MS-C18
ATLANTA,  GA  30333
Applicant Contact Yon Yu, Pharm.D.
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON ROAD, MS-C18
ATLANTA,  GA  30333
Correspondent Contact Yon Yu, Pharm.D.
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD  
Date Received07/10/2014
Decision Date 08/01/2014
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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