Adaptive Biotechnologies clonoSEQ Assay— 510(k) K200009

Name: FDA 510(k) clearance K200009
Creator: U.S. Food and Drug Administration
Published: 2020-08-05

Substantially Equivalent

Adaptive Biotechnologies Corporation

FDA 510(k) clearance K200009 for Adaptive Biotechnologies clonoSEQ Assay, Substantially Equivalent on 2020-08-05. Applicant: Adaptive Biotechnologies Corporation. Device class: 2.

Clearance details

Applicant: Adaptive Biotechnologies Corporation
Product code: Code QDC
Device class: Class 2
Regulation: 21 CFR 866.6100
Advisory panel: Pathology
Date received: 2020-01-02
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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