FDA applicant

Spectral Diagnostics, Inc.

Toronto, Ontario, CA12 decisions1997–20060 recalls

FDA records 12 decisions for Spectral Diagnostics, Inc. (Toronto, Ontario, CA) from 1997 to 2006: 11 510(k) clearances and 1 De Novo grant. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 1 predicate, 0 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Spectral Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectral Diagnostics, Inc.’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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Other applicant names beginning “Spectral”

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

Spectral Data Systems 2 Spectral Medical, Inc. 2 Spectral Visualization & Development, Inc. 1

Spectral Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spectral”