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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
904 Caribbean Drive
sunnyvale,  CA  94089
Applicant Contact yi-ping lin
904 Caribbean Drive
sunnyvale,  CA  94089
Correspondent Contact jim kelly
Regulation Number866.2680
Classification Product Code
Subsequent Product Code
Date Received10/31/2017
Decision Date 04/26/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
CLIA Waiver CLIA Waiver Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No