The following data is part of a premarket notification filed by Adaptive Biotechnologies Corporation with the FDA for Adaptive Biotechnologies Clonoseq Assay.
| Device ID | K200009 |
| 510k Number | K200009 |
| 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 | Megan Duncan |
| Correspondent | Pamela Swatkowski Adaptive Biotechnologies Corporation 1551 Eastlake Ave E., Ste 200 Seattle, WA 98102 |
| Product Code | QDC |
| CFR Regulation Number | 866.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-02 |
| Decision Date | 2020-08-05 |