FDA product code LAM: High Pressure Liquid Chromatography, Quinine
LAM is the FDA product code for high pressure liquid chromatography, quinine. It is a Class I device, regulated under 21 CFR 862.3750 and reviewed by the Clinical Toxicology panel. Devices under LAM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Quinine |
| Device class | Class I |
| Regulation | 21 CFR 862.3750 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LAM devices
openFDA lists no recalls for product code LAM.
Frequently asked questions
What is FDA product code LAM?
LAM is the FDA product code for high pressure liquid chromatography, quinine. It is a Class I device, regulated under 21 CFR 862.3750 and reviewed by the Clinical Toxicology panel.
What device class is LAM?
Class I, regulation 21 CFR 862.3750. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LAM
- Run a recall and safety report across every LAM manufacturer
- Watch product code LAM 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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