510(k) Report

FDA applicant

Institute Virion, Ltd.

Mchenry, IL16 decisions1984–19860 recalls

FDA records 16 decisions for Institute Virion, Ltd. (Mchenry, IL) from 1984 to 1986: 16 510(k) clearances. Most are in product codes GNX (Antigens, Cf (Including Cf Control), Influenza…) and GQS (Antigens, Cf (Including Cf Control)…). 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 Institute Virion, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Institute Virion, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Institute”

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