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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
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02786381
Reviewed by Third Party No
Combination Product No
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