FDA applicant
Alexon Biomedical, Inc.
FDA records 5 decisions for Alexon Biomedical, Inc. (Sunnyvale, CA) from 1988 to 1997: 5 510(k) clearances. Most are in product codes MHI (Giardia Spp.) and KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica &…). 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 Alexon Biomedical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Alexon Biomedical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alexon Biomedical, Inc.’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 “Alexon”
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