FDA applicant

Copan Diagnostics, Inc.

North Attleboro, MA10 decisions1995–20062 recalls

FDA records 10 decisions for Copan Diagnostics, Inc. (North Attleboro, MA) from 1995 to 2006: 10 510(k) clearances. Most are in product codes JSM (Culture Media, Non-Propagating Transport) and JTW (System, Transport, Aerobic). Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

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

FDA decisions per year

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

Recalls per year

1in 2025

2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Copan 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 “Copan”

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

Copan Italia Spa 8 Copan Wasp Srl 5 Copan Flock Technologies 1

Copan 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?

What has been recalled?

Other applicant names beginning “Copan”