510(k) Report

FDA applicant

Molecularmd Corporation

Portland, OR1 decision2017–20170 recalls

FDA records 1 decision for Molecularmd Corporation (Portland, OR) in 2017: 1 510(k) clearance. All are in product code OYX (Bcr/Abl1 Monitoring Test). No recall is linked to its devices.

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

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

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Molecularmd Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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