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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 virus subtype differentiation nucleic acid assay
510(k) Number K140851
Device Name INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON ROAD, MAILSTOP D-30
atlanta,  GA  30333
Applicant Contact cdr yon yu, pharm.d.
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON ROAD, MAILSTOP D-30
atlanta,  GA  30333
Correspondent Contact cdr yon yu, pharm.d.
Regulation Number866.3980
Classification Product Code
OEP  
Date Received04/03/2014
Decision Date 04/25/2014
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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