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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
CLIA Waiver CLIA Waiver Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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