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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bcr/abl1 monitoring test
510(k) Number K190076
Device Name Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Yi-Ping Lin
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Sudhakar Marla
Regulation Number866.6060
Classification Product Code
Subsequent Product Code
Date Received01/16/2019
Decision Date 09/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No