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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
510(k) Number K190441
Device Name Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
Applicant
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Applicant Contact yi-ping lin
Correspondent
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Correspondent Contact sudhakar marla
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OOI   QBD  
Date Received02/25/2019
Decision Date 05/23/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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