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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 amplification assay system, group b streptococcus, direct specimen test
510(k) Number K203429
Device Name Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Yi-Ping Lin
Correspondent
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Robert Resnick
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received11/20/2020
Decision Date 05/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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