510(k) DEN170080
- Device
- Adaptive Biotechnologies clonoSEQ Assay
- Applicant
- Adaptive Biotechnologies Corporation
- 510(k) number
- DEN170080
- Product code
- QDC
- Decision
- Unknown (DENG)
- Decision date
- 2018-09-28
- Date received
- 2017-09-29
- Regulation
- 866.6100
- Classification name
- Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- B. Melina Cimler
- Address
- 1551 Eastlake Ave. E., Suite 200 Seattle WA US 98102 98102
FDA Registration Numbers#
- 3009879426
- 3004530258
- 3016838963
- 3019895551
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QDC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2020-08-05 |