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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K163636
Device Name ePlex Respiratory Pathogen Panel
Applicant
GENMARK DIAGNOSTICS, INCORPORATED
5964 LA PLACE COURT
carlsbad,  CA  92008
Applicant Contact alan maderazo
Correspondent
GENMARK DIAGNOSTICS, INCORPORATED
5964 LA PLACE COURT
carlsbad,  CA  92008
Correspondent Contact alan maderazo
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NSU   OEM   OEP   OOU   OQW  
OTG   OZE   OZX   OZY  
Date Received12/22/2016
Decision Date 06/09/2017
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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