FDA product code OXR: 5-Fluorouracil Assay
OXR is the FDA product code for 5-fluorouracil assay. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under OXR reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Measures levels of a chemotherapy drug in the blood.
Classification
| Field | Value |
|---|---|
| Device name | 5-Fluorouracil Assay |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OXR devices
openFDA lists no recalls for product code OXR.
Frequently asked questions
What is FDA product code OXR?
OXR is the FDA product code for 5-fluorouracil assay. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is OXR?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OXR
- Run a recall and safety report across every OXR manufacturer
- Watch product code OXR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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