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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 K181736
Device Name CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
Applicant
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road
MS E-51
Atlanta,  GA  30329 -4027
Applicant Contact Yon Yu
Correspondent
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road
MS E-51
Atlanta,  GA  30329 -4027
Correspondent Contact Yon Yu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   OOI  
Date Received07/02/2018
Decision Date 07/30/2018
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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