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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, Influenza A/HS Subtyping Kit
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
Predetermined Change
Control Plan Authorized		 No
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