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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 K173492
Device Name MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
Applicant
MolecularMD Corporation
1341 SW Custer Drive
Portland,  OR  97219
Applicant Contact Kevin Hawkins
Correspondent
MolecularMD Corporation
1341 SW Custer Drive
Portland,  OR  97219
Correspondent Contact Kevin Hawkins
Regulation Number866.6060
Classification Product Code
OYX  
Date Received11/13/2017
Decision Date 12/22/2017
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01698905
NCT01784068
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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