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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
Applicant
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Yen H. Nguyen
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
OOI  
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
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