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510(k) K200009

Device
Adaptive Biotechnologies ClonoSEQ Assay
Applicant
Adaptive Biotechnologies Corporation
510(k) number
K200009
Product code
QDC  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-05
Date received
2020-01-02
Regulation
866.6100
Classification name
Dna-based Test For Minimal Residual Disease For Hematologic Malignancies
Medical specialty
Pathology
Review panel
Molecular Genetics
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Megan Duncan
Address
1551 Eastlake Ave. E., Suite 200 Seattle WA US 98102 98102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN170080Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation2018-09-28

Legacy Summary#

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FDA Review#

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