FDA applicant
Orgenics, Ltd.
FDA records 3 decisions for Orgenics, Ltd. (Washington, DC) from 1989 to 1990: 3 510(k) clearances. Most are in product codes LJC (Enzyme Linked Immunoabsorbent Assay…) and LFZ (Enzyme Linked Immunoabsorbent Assay…). 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 Orgenics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orgenics, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orgenics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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