510(k) Report

FDA applicant

Oxis Intl., Inc.

Portland, OR11 decisions1995–19970 recalls

FDA records 11 decisions for Oxis Intl., Inc. (Portland, OR) from 1995 to 1997: 11 510(k) clearances. Most are in product codes LGQ (Fluorescence Polarization Immunoassay…) and LGR (Fluorescence Polarization Immunoassay…). 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 toxicology panel, where it files most

How often FDA has decided Oxis Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oxis Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oxis Intl., Inc.’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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