510(k) Report

FDA applicant

Lxn Corp.

San Diego, CA7 decisions1996–20010 recalls

FDA records 7 decisions for Lxn Corp. (San Diego, CA) from 1996 to 2001: 7 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and LCP (Assay, Glycosylated Hemoglobin). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Lxn Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lxn Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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