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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
510(k) Number K231381
Device Name Xpert Xpress MVP; GeneXpert Xpress System
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Wei Zhang
Classification Product Code
PQA  
Subsequent Product Code
OOI  
Date Received05/12/2023
Decision Date 10/19/2023
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
Predetermined Change
Control Plan Authorized		 No
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