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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
510(k) Number K143302
Device Name Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact KERRY J FLOM
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent Contact PAMELA JOHNSON
Regulation Number866.3373
Classification Product Code
PEU  
Date Received11/17/2014
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01587469
Reviewed by Third Party No
Combination Product No
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