FDA applicant

Orion Diagnostica, Div. Orion Corp.

Espoo, FI4 decisions1995–20030 recalls

FDA records 4 decisions for Orion Diagnostica, Div. Orion Corp. (Espoo, FI) from 1995 to 2003: 4 510(k) clearances. Most are in product codes DCK (C-Reactive Protein, Antigen, Antiserum, And…) and LYR (Helicobacter Pylori). 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 Orion Diagnostica, Div. Orion Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orion Diagnostica, Div. Orion Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orion Diagnostica, Div. Orion Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Orion”

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

Orion Life Systems, Inc. 33 Orion Diagnostica, Inc. 32 Orion Corp. 21 Orion Corporation Soredex 4 Orion Industries 1 Orion Biotech, Inc. 1

Orion Diagnostica, Div. Orion Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Orion”