FDA applicant

Sweden Diagnostics (Germany) GmbH

Freiburg, DE8 decisions2004–20050 recalls

FDA records 8 decisions for Sweden Diagnostics (Germany) GmbH (Freiburg, DE) from 2004 to 2005: 8 510(k) clearances. Most are in product codes MST (Antibodies, Gliadin) and LJM (Antinuclear Antibody (Enzyme-Labeled)…). Its devices cite 4 predicates, 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 Sweden Diagnostics (Germany) GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sweden Diagnostics (Germany) GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sweden Diagnostics (Germany) GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Sweden”

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

Sweden & Martina S.P.A. 8 Sweden Diagnostics (Us), Inc. 1

Sweden Diagnostics (Germany) GmbH

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 “Sweden”