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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 Rd.
Ms E-51
Atlanta,  GA  30329 -4027
Applicant Contact Yon Yu
Correspondent
Centers For Disease Control and Prevention (Cdc)
1600 Clifton Rd.
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
Predetermined Change
Control Plan Authorized		 No
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