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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 K092953
Device Name Xpert VanA Assay
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact RUSSEL K ENNS
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent Contact Riva Dill-Garlow
Regulation Number866.1640
Classification Product Code
NIJ  
Subsequent Product Code
OOI  
Date Received09/24/2009
Decision Date 12/17/2009
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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