510(k) Report

FDA applicant

Adaptive Biotechnologies Corporation

Seattle, WA2 decisions2018–20200 recalls

FDA records 2 decisions for Adaptive Biotechnologies Corporation (Seattle, WA) from 2018 to 2020: 1 510(k) clearance and 1 De Novo grant. All are in product code QDC (Dna-Based Test For Minimal Residual Disease…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Adaptive Biotechnologies Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Adaptive Biotechnologies Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Adaptive”

FDA records each applicant name separately; these may or may not be the same firm.