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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K151226
Device Name Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
Applicant
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Applicant Contact Kerry J Flom
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale,  CA  94089
Correspondent Contact Scott A Campbell
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JSM   OOI  
Date Received05/07/2015
Decision Date 12/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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