Device Classification Name |
dna-based test for minimal residual disease for hematologic malignancies
|
De Novo Number |
DEN170080 |
Device Name |
Adaptive Biotechnologies clonoSEQ Assay |
Requester |
adaptive biotechnologies corporation |
1551 eastlake ave e, ste 200 |
seattle,
WA
98102
|
|
Contact |
b. melina cimler |
|
Regulation Number | 866.6100
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 09/28/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Pathology
|
Review Advisory Committee |
Pathology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|