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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory specimen nucleic acid sars-cov-2 test
510(k) Number K230440
Device Name Xpert® Xpress CoV-2 plus
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Jennifer Motto
Regulation Number866.3981
Classification Product Code
Date Received02/21/2023
Decision Date 10/13/2023
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