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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 K181661
Device Name QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Applicant
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Pleasanton,  CA  94588
Applicant Contact Steve Lin
Correspondent
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Pleasanton,  CA  94588
Correspondent Contact Steve Lin
Regulation Number866.6060
Classification Product Code
OYX  
Subsequent Product Code
PHG  
Date Received06/25/2018
Decision Date 02/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Molecular Genetics
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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