FDA applicant
Agen Biomedical, Ltd.
FDA records 6 decisions for Agen Biomedical, Ltd. (Brisbane, AU) from 1988 to 1999: 6 510(k) clearances. Most are in product codes DAP (Fibrinogen And Fibrin Split Products, Antigen…) and GHH (Fibrin Split Products). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Agen Biomedical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Agen Biomedical, Ltd. since 2007.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Agen Biomedical, 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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