Adaptive Biotechnologies clonoSEQ Assay
FDA 510(k) clearance K200009 · decided 2020-08-05
Clearance details
- K-number
- K200009
- Device name
- Adaptive Biotechnologies clonoSEQ Assay
- Applicant
- Adaptive Biotechnologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-01-02
- Decision date
- 2020-08-05
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- QDC
- Device class
- 2
- Regulation number
- 866.6100
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Adaptive Biotechnologies clonoSEQ Assay (DEN170080) | Adaptive Biotechnologies Corporation | 2018-09-28 |
Recalls involving this device
No recalls on record reference this clearance.