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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 K180218
Device Name Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Applicant
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Applicant Contact yi-ping lin
Correspondent
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Correspondent Contact jim kelly
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JSM   OOI  
Date Received01/25/2018
Decision Date 07/24/2018
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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