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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name dna-based test for minimal residual disease for hematologic malignancies
De Novo Number DEN170080
Device Name Adaptive Biotechnologies clonoSEQ Assay
Adaptive Biotechnologies Corporation
1551 eastlake ave e, ste 200
seattle,  WA  98102
Contact b. melina cimler
Regulation Number866.6100
Classification Product Code
Date Received09/29/2017
Decision Date 09/28/2018
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct