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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
Applicant
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Jennifer Motto
Regulation Number866.3981
Classification Product Code
QQX  
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
Predetermined Change
Control Plan Authorized		 No
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