FDA product code LPX: Radioceptor Assay, Neuroleptic Drugs
LPX is the FDA product code for radioceptor assay, neuroleptic drugs. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. Devices under LPX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioceptor Assay, Neuroleptic Drugs |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LPX devices
openFDA lists no recalls for product code LPX.
Frequently asked questions
What is FDA product code LPX?
LPX is the FDA product code for radioceptor assay, neuroleptic drugs. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is LPX?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LPX
- Run a recall and safety report across every LPX manufacturer
- Watch product code LPX 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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