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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-based test for minimal residual disease for hematologic malignancies
510(k) Number K200009
Device Name Adaptive Biotechnologies clonoSEQ Assay
Applicant
Adaptive Biotechnologies Corporation
1551 Eastlake Ave E., Ste 200
seattle,  WA  98102
Applicant Contact megan duncan
Correspondent
Adaptive Biotechnologies Corporation
1551 Eastlake Ave E., Ste 200
seattle,  WA  98102
Correspondent Contact pamela swatkowski
Regulation Number866.6100
Classification Product Code
QDC  
Date Received01/02/2020
Decision Date 08/05/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Molecular Genetics
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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