Data / Medical devices / United States / Adaptive Biotechnologies
Adaptive Biotechnologies: FDA-registered device maker in Seattle, WA, United States, 2 510(k) clearances
Adaptive Biotechnologies is registered with the FDA (registration 3019895551) in Seattle, WA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019895551
- Address
- 1165 Eastlake Avenue East, Seattle, WA, United States, 98109
- Owner or operator
- Adaptive Biotechnologies (10059613)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 4, 2019
- Registered through
- 2026
- Brand names listed
- clonoSEQ® Assay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | QDC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2020 | K200009 | Adaptive Biotechnologies clonoSEQ Assay | QDC | Substantially Equivalent | Adaptive Biotechnologies Corporation | accessdata.fda.gov |
| September 28, 2018 | DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | QDC | Unknown | Adaptive Biotechnologies Corporation | accessdata.fda.gov |
Compare with other makers
Updated August 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.