FDA product code NFY: Test, Cocaine And Cocaine Metabolites, Over The Counter
NFY is the FDA product code for test, cocaine and cocaine metabolites, over the counter. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. Devices under NFY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NFY devices
openFDA lists no recalls for product code NFY.
Frequently asked questions
What is FDA product code NFY?
NFY is the FDA product code for test, cocaine and cocaine metabolites, over the counter. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is NFY?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NFY
- Run a recall and safety report across every NFY manufacturer
- Watch product code NFY 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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