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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 K181289
Device Name Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Yi-Ping Lin
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Jim Kelly
Regulation Number866.3980
Classification Product Code
Subsequent Product Codes
Date Received05/16/2018
Decision Date 08/15/2018
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