The following data is part of a De Novo classification by Adaptive Biotechnologies Corporation with the FDA for Adaptive Biotechnologies Clonoseq Assay.
| DeNovo ID | DEN170080 |
| Device Name: | Adaptive Biotechnologies ClonoSEQ Assay |
| Classification | Dna-based Test For Minimal Residual Disease For Hematologic Malignancies |
| Applicant | Adaptive Biotechnologies Corporation 1551 Eastlake Ave E, Ste 200 Seattle, WA 98102 |
| Contact | B. Melina Cimler |
| Product Code | QDC |
| CFR Regulation Number | 866.6100 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Pathology |
| Classification Advisory | Pathology |
| Type | Direct |
| Date Received | 2017-09-29 |
| Decision Date | 2018-09-28 |
| Reclassification Order: | Reclassification Order |