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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K173398
Device Name Xpert Xpress Strep A
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 Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received10/31/2017
Decision Date 04/26/2018
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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