Adaptive Biotechnologies ClonoSEQ Assay

Dna-based Test For Minimal Residual Disease For Hematologic Malignancies

Adaptive Biotechnologies Corporation

The following data is part of a De Novo classification by Adaptive Biotechnologies Corporation with the FDA for Adaptive Biotechnologies Clonoseq Assay.

Pre-market Notification Details

DeNovo IDDEN170080
Device Name:Adaptive Biotechnologies ClonoSEQ Assay
ClassificationDna-based Test For Minimal Residual Disease For Hematologic Malignancies
Applicant Adaptive Biotechnologies Corporation 1551 Eastlake Ave E, Ste 200 Seattle,  WA  98102
ContactB. Melina Cimler
Product CodeQDC  
CFR Regulation Number866.6100 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardPathology
Classification AdvisoryPathology
TypeDirect
Date Received2017-09-29
Decision Date2018-09-28
Reclassification Order:Reclassification Order

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