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Adaptive Biotechnologies clonoSEQ Assay

DEN170080 Class II Direct
Decision Date
2018-09-28
Sponsor / Applicant
Adaptive Biotechnologies Corporation

Technical Specification

510(k) Submission ID DEN170080
Product Code QDC
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 866.6100
Decision Date 2018-09-28
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Adaptive Biotechnologies clonoSEQ Assay received FDA 510(k) clearance under submission number DEN170080, sponsored by Adaptive Biotechnologies Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2018-09-28.

Classification & Regulation

This clearance is catalogued under FDA product code QDC and 21 CFR 866.6100, within the Pathology review panel as a Class II device.