FDA product code CFO: Titrimetric, Magnesium
CFO is the FDA product code for titrimetric, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel. Devices under CFO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Titrimetric, Magnesium |
| Device class | Class I |
| Regulation | 21 CFR 862.1495 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CFO devices
openFDA lists no recalls for product code CFO.
Frequently asked questions
What is FDA product code CFO?
CFO is the FDA product code for titrimetric, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel.
What device class is CFO?
Class I, regulation 21 CFR 862.1495. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CFO
- Run a recall and safety report across every CFO manufacturer
- Watch product code CFO 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times