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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
510(k) Number K231481
Device Name Xpert Xpress CoV-2/Flu/RSV plus
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Yen H. Nguyen
Regulation Number866.3981
Classification Product Code
Subsequent Product Code
Date Received05/23/2023
Decision Date 08/17/2023
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