FDA product code LAK: High Pressure Liquid Chromatography, Propoxyphene
LAK is the FDA product code for high pressure liquid chromatography, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel. Devices under LAK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Propoxyphene |
| Device class | Class II |
| Regulation | 21 CFR 862.3700 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LAK devices
openFDA lists no recalls for product code LAK.
Frequently asked questions
What is FDA product code LAK?
LAK is the FDA product code for high pressure liquid chromatography, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel.
What device class is LAK?
Class II, regulation 21 CFR 862.3700. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LAK
- Run a recall and safety report across every LAK manufacturer
- Watch product code LAK 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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