FDA applicant

Royco Instruments

Mchenry, IL4 decisions1979–19800 recalls

FDA records 4 decisions for Royco Instruments (Mchenry, IL) from 1979 to 1980: 4 510(k) clearances. Most are in product codes GIF (Diluent, Blood Cell) and GKL (Counter, Cell, Automated (Particle Counter)). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Royco Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Royco Instruments

Which product codes does it file in?

What has FDA decided for it lately?