510(k) Report

FDA applicant

Orion Corp.

20101 Turku, FI21 decisions1985–19920 recalls

FDA records 21 decisions for Orion Corp. (20101 Turku, FI) from 1985 to 1992: 21 510(k) clearances. Most are in product codes LQN (Latex Agglutination Assay, Rubella) and JSI (Culture Media, Selective And Differential). 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, microbiology panel, where it files most

How often FDA has decided Orion Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orion Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 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.