FDA applicant
Institute Virion, Ltd.
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
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.
Planning a device like Institute Virion, Ltd.’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) ReportOther applicant names beginning “Institute”
FDA records each applicant name separately; these may or may not be the same firm.