510(k) Report

FDA applicant

Alexon Biomedical, Inc.

Sunnyvale, CA5 decisions1988–19972 recalls

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, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

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.

FIG. 1 — Alexon Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Alexon”

FDA records each applicant name separately; these may or may not be the same firm.