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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
Predetermined Change
Control Plan Authorized		 No
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