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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 K190302
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 B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR,
Applicant
Centers for Disease Control and Prevention
1600 Clifton Rd; MS VI 8-4
atlanta,  GA  30329
Applicant Contact yon yu
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Rd; MS VI 8-4
atlanta,  GA  30329
Correspondent Contact yon yu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   NXD   OEP   OOI   OQW  
Date Received02/12/2019
Decision Date 03/27/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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