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Adaptive Biotechnologies Corporation

FDA Regulatory Profile

Adaptive Biotechnologies Corporation has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 24, 2025 · NAI
Latest 510(k)
Aug 5, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 24, 2025Bothell, WADevicesNo Action Indicated (NAI)3009879426
Oct 29, 2021Bothell, WADevicesNo Action Indicated (NAI)3009879426

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K200009Adaptive Biotechnologies clonoSEQ AssayAug 5, 2020
DEN170080Adaptive Biotechnologies clonoSEQ AssaySep 28, 2018

FDA data resources