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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 K163628
Device Name Idylla Respiratory (IFV-RSV) Panel
Applicant
JANSSEN PHARMACEUTICA NV
TURNHOUTSEWEG 30
BEERSE,  BE 2340
Applicant Contact SARAH PARSONS
Correspondent
JANSSEN RESEARCH & DEVELOPMENT LLC
920 US HIGHWAY 202
RARITAN,  NJ  08869
Correspondent Contact SARAH PARSONS
Regulation Number866.3980
Classification Product Code
OCC  
Date Received12/22/2016
Decision Date 08/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02786381
Reviewed by Third Party No
Combination Product No
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