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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
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