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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 K200370
Device Name CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
Applicant
Centers For Disease Control And Prevention
1600 Clifton Rd; MS H24-11
Atlanta,  GA  30329
Applicant Contact Yon Yu
Correspondent
Centers For Disease Control And Prevention
1600 Clifton Rd; MS H24-11
Atlanta,  GA  30329
Correspondent Contact Yon Yu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD   OEP   OOI   OQW  
Date Received02/14/2020
Decision Date 03/10/2020
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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