510(k) Report

FDA applicant

Oxford Immunotec, Ltd.

Milton Park, Abingdon Oxfordshire1 decision2008–20080 recalls

FDA records 1 decision for Oxford Immunotec, Ltd. (Milton Park, Abingdon Oxfordshire) in 2008: 1 original PMA approval. All are in product code OJN (Mycobacterium Tuberculosis, Cell Mediated…). 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, microbiology panel, where it files most

How often FDA has decided Oxford Immunotec, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Oxford Immunotec, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oxford Immunotec, 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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Other applicant names beginning “Oxford”

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