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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 Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Dr.
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
Predetermined Change
Control Plan Authorized		 No
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