FDA product code LAL: Eas Chromatography, Quinine
LAL is the FDA product code for eas chromatography, quinine. It is a Class I device, regulated under 21 CFR 862.3750 and reviewed by the Clinical Toxicology panel. Devices under LAL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Eas 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 LAL devices
openFDA lists no recalls for product code LAL.
Frequently asked questions
What is FDA product code LAL?
LAL is the FDA product code for eas 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 LAL?
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 LAL
- Run a recall and safety report across every LAL manufacturer
- Watch product code LAL 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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