Adaptive Biotechnologies clonoSEQ Assay— 510(k) DEN170080

Name: FDA 510(k) clearance DEN170080
Creator: U.S. Food and Drug Administration
Published: 2018-09-28

Unknown

Adaptive Biotechnologies Corporation

FDA 510(k) clearance DEN170080 for Adaptive Biotechnologies clonoSEQ Assay, Unknown on 2018-09-28. 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: 2017-09-29
Decision date: 2018-09-28
Decision: Unknown
Clearance type: Direct
Location: Seattle, WA, US

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