FDA applicant
Progene Corp.
FDA records 3 decisions for Progene Corp. (Overland Park, KS) from 1988 to 1989: 3 510(k) clearances. Most are in product codes DGC (Ige, Antigen, Antiserum, Control) and JIR (Indicator Method, Protein Or Albumin (Urinary…). 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 Progene Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Progene Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Progene Corp.’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) Report