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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
510(k) Number K243405
Device Name Xpert vanA
Applicant
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Riva Dill-Garlow
Regulation Number866.1640
Classification Product Code
NIJ  
Subsequent Product Code
OOI  
Date Received11/01/2024
Decision Date 11/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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