FDA applicant

Sqi Diagnostics Systems

Toronto, On, CA3 decisions2009–20140 recalls

FDA records 3 decisions for Sqi Diagnostics Systems (Toronto, On, CA) from 2009 to 2014: 3 510(k) clearances. Most are in product codes MVM (Autoantibodies, Endomysial (Tissue…) and DHR (System, Test, Rheumatoid Factor). Its devices cite 10 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sqi Diagnostics Systems, Inc.”.

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

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

How often FDA has decided Sqi Diagnostics Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sqi Diagnostics Systems by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sqi Diagnostics Systems

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?