510(k) Report

FDA applicant

Tm Bioscience Corporation

Toronto, Ontario, CA2 decisions2005–20060 recalls

FDA records 2 decisions for Tm Bioscience Corporation (Toronto, Ontario, CA) from 2005 to 2006: 1 510(k) clearance and 1 De Novo grant. All are in product code NUA (System, Cystic Fibrosis Transmembrane…). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Tm Bioscience Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tm Bioscience Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tm Bioscience Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2decisions

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 20056cite it
  • K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 20062cite it

What has FDA decided for it lately?

  • K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006
  • DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005

All 2 as Tm Bioscience Corporation →