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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vaginitis and bacterial vaginosis nucleic acid detection system
510(k) Number K212213
Device Name Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Wei Zhang
Regulation Number866.3975
Classification Product Code
Subsequent Product Code
Date Received07/15/2021
Decision Date 02/09/2022
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